A number of company acquisitions were made in June, which will have a bearing on the global generic markets, with acquisitions taking place in the Americas and Europe. In addition, a new strategic agreement was signed in South Africa.
In Argentina, GlaxoSmithKline announced that it had acquired Laboratorios Phoenix. GlaxoSmithKline commented that it was making the acquisition to help accelerate sales growth and further extend its product portfolio in Argentina and Latin America. Laboratorios Phoenix was founded in Buenos Aires in 1939, and manufactures branded generic products covering therapeutic areas such as cardiovascular, gastroenterology, metabolism and urology. GlaxoSmithKline's acquisition follows a recent trend of branded firms taking a closer interest in generic firms.
Along similar lines, although not an acquisition, was the announcement made by Adcock Ingram and Merck & Co, through its MSD trading name, of a strategic collaboration in South Africa. The collaboration is to co-promote and distribute a number of MSD products in South Africa, including both prescription medicines and over-the-counter products. Merck reasoned that it sees the emerging markets as becoming an important contributor for future performance and growth, and expects such markets to account for over 25% of its global pharmaceutical and vaccine revenues in 2013. Merck has thus become one of a number of large branded companies in recent times to see a future in the emerging and developing markets, leading to strategic tie-ins with local firms. There has been most notably a surge of multinational firms making deals with particularly Indian generic companies.
However, the Indian firms themselves have also shown this to be a two-way street. India's Orchid Chemicals & Pharmaceuticals announced in June that it was to acquire a US-based generic manufacturing and sales services company, Karalex Pharma. Orchid declined to name its price; the acquisition was completed on 2nd July. Orchid aims for the acquisition to help it create itself as a US-based generic pharmaceutical company, and the move gives the firm a presence in the front-end US market. Separately, in March 2010, Orchid sold its generic injectable business to Hospira, completing a US$400 million deal which was announced in December 2009. Coincidentally, alongside Orchid's Karalex acquisition, Hospira announced its first generic drug launch from its Orchid acquisition, with the launch of its meropenem for injection, a generic equivalent of AstraZeneca's Merrem IV.
Elsewhere, in Europe, Lithuania's Sanitas announced that it had sold the manufacturing site of its Slovakian subsidiary, HBM Pharma, to a Latvian firm, Liplats 2000. HBM Pharma had, prior to Sanitas' own acquisition of it, been known as Hoechst Biotika, and Sanitas had acquired it in 2005 from sanofi-aventis. However, Sanitas is keeping hold of HBM Pharma's marketing, sales and regulatory divisions, located in Bratislava and Prague. After Sanitas acquired HBM Pharma from sanofi-aventis, the firm worked to integrate the business into the Sanitas group as a manufacturing unit and as a hub to commence sales and marketing in neighbouring countries. This part of the business is clearly still of interest to Sanitas.
Ian Platts – Editor, World Generic Markets
Tuesday, July 20, 2010
Friday, June 18, 2010
SOHM branches out
In late May 2010, SOHM announced that it was branching out, with a sales and marketing agreement to sell its branded generics in Uganda, Tanzania and Zambia and a purchase order for generics for distribution in the Philippines. SOHM is a relative newcomer to the generics industry; it has global headquarters located in North America but has manufacturing sites in India; the firm chose to set up its manufacturing operations in India in order to take advantage of the country's strong marketing set up, low prices and the fact that it uses English as a business language. The firm produces and markets generics with an eye on distribution in the emerging markets in Africa, Latin America and Southeast Asia. SOHM's strategy is to increase its market share in the firm's defined key markets in the emerging world, arguing that growth is shifting away from the developed markets of the United States and Europe and toward emerging markets as less developed countries prosper and spend more on healthcare.
The recently-announced Philippines purchase order is worth US$750,000, and covers primarily metformin and sildenafil citrate; a rather odd combination of a type 2 diabetes treatment and the generic form of Pfizer's Viagra, which says as much about SOHM's production capabilities as it does about medical and lifestyle conditions that are becoming increasingly profitable in the Philippines. In July 2009, the firm announced that it had received Philippine Bureau of Food and Drug Administration (BFAD) registration for generic pharmaceutical sales. SOHM was more circumspect about its new African operations, declining to name either the branded drugs at the heart of the sales and marketing agreement or the African partner it was teaming up with.
SOHM has over the past 18 months made agreements with a number of companies, and has, on the whole, been careful not to divulge too much information. In January 2009, the firm announced an exclusive private label and development agreement with an Indian firm, which it refused to name, but noted that the two firms had formed a global platform for the introduction of the SOHM brand of generics into the African, Latin American and Southeast Asian markets. Under this agreement, generics would be labelled under the SOHM brand and would be distributed directly under the firm's manufacturing licence in India. In September 2009, SOHM announced that it had launched 26 branded generics in India, adding that it had appointed two distributors in Northern India, which were again unnamed. In February this year, the firm announced it had signed another marketing agreement which would add 75 branded generics for distribution across India, taking the firm's total offerings to 135; again the name of the company it had signed the agreement with was not revealed. Around the same time, SOHM reported that it had signed a strategic alliance with an injectable manufacturing unit in India. The firm said little else, but noted that the agreement would add another 89 injectable and drops-based generics to its portfolio, bringing the total to 279. In May, the firm announced this figure had risen to 280.
Aside from generics, the SOHM has also recently announced that it has expanded its manufacturing operations in Ahmadabad, India, to include improved nutraceutical product production. A new facility will concentrate on neutracueticals, leaving the pharmaceutical manufacturing facility free to focus on generic drug orders exclusively. At the same time, the firm announced a purchase order for nutraceutical products in India valued at US$350,000.
The dollar figures SOHM is dealing in are perhaps small by the standards of most generic firms with international operations, and certainly tiny in comparison to other generic firms based in North America. The Philippine drug order and the Indian nutraceutical order have a combined value of US$1.1 million, which is a reasonable total, but far from stellar. Nonetheless, SOHM's talk is all about expansion and tapping into growing markets in previously under-represented regions. This can be seen in the firm's financial performance. In May 2010, the firm announced revenues for the first quarter ended 31st March 2010 worth US$200,324; again, tiny by international standards, but an improvement over the prior year period's US$29,598 of over 600%. Especially in the current economic climate and despite countries in North America, Europe and Japan announcing determination to increase generic spending to reduce healthcare budgets, the vast majority of generic firms around the world can only dream of increasing revenues by such an amount.
Ian Platts - Editor, World Generic Markets
The recently-announced Philippines purchase order is worth US$750,000, and covers primarily metformin and sildenafil citrate; a rather odd combination of a type 2 diabetes treatment and the generic form of Pfizer's Viagra, which says as much about SOHM's production capabilities as it does about medical and lifestyle conditions that are becoming increasingly profitable in the Philippines. In July 2009, the firm announced that it had received Philippine Bureau of Food and Drug Administration (BFAD) registration for generic pharmaceutical sales. SOHM was more circumspect about its new African operations, declining to name either the branded drugs at the heart of the sales and marketing agreement or the African partner it was teaming up with.
SOHM has over the past 18 months made agreements with a number of companies, and has, on the whole, been careful not to divulge too much information. In January 2009, the firm announced an exclusive private label and development agreement with an Indian firm, which it refused to name, but noted that the two firms had formed a global platform for the introduction of the SOHM brand of generics into the African, Latin American and Southeast Asian markets. Under this agreement, generics would be labelled under the SOHM brand and would be distributed directly under the firm's manufacturing licence in India. In September 2009, SOHM announced that it had launched 26 branded generics in India, adding that it had appointed two distributors in Northern India, which were again unnamed. In February this year, the firm announced it had signed another marketing agreement which would add 75 branded generics for distribution across India, taking the firm's total offerings to 135; again the name of the company it had signed the agreement with was not revealed. Around the same time, SOHM reported that it had signed a strategic alliance with an injectable manufacturing unit in India. The firm said little else, but noted that the agreement would add another 89 injectable and drops-based generics to its portfolio, bringing the total to 279. In May, the firm announced this figure had risen to 280.
Aside from generics, the SOHM has also recently announced that it has expanded its manufacturing operations in Ahmadabad, India, to include improved nutraceutical product production. A new facility will concentrate on neutracueticals, leaving the pharmaceutical manufacturing facility free to focus on generic drug orders exclusively. At the same time, the firm announced a purchase order for nutraceutical products in India valued at US$350,000.
The dollar figures SOHM is dealing in are perhaps small by the standards of most generic firms with international operations, and certainly tiny in comparison to other generic firms based in North America. The Philippine drug order and the Indian nutraceutical order have a combined value of US$1.1 million, which is a reasonable total, but far from stellar. Nonetheless, SOHM's talk is all about expansion and tapping into growing markets in previously under-represented regions. This can be seen in the firm's financial performance. In May 2010, the firm announced revenues for the first quarter ended 31st March 2010 worth US$200,324; again, tiny by international standards, but an improvement over the prior year period's US$29,598 of over 600%. Especially in the current economic climate and despite countries in North America, Europe and Japan announcing determination to increase generic spending to reduce healthcare budgets, the vast majority of generic firms around the world can only dream of increasing revenues by such an amount.
Ian Platts - Editor, World Generic Markets
Tuesday, June 8, 2010
Orbus files for bankruptcy
Canada's Orbus Pharma announced in May 2010 that it had gained protection from its creditors under the provisions of the Bankruptcy and Insolvency Act. The move came as a result of a number of financial difficulties the firm has faced in recent times. Orbus was originally known as Bovar, created in Calgary, Alberta in June 1977. In May 2002, the firm completed the purchase and subsequent amalgamation with Orbus Life Sciences, a firm which had begun operations in April 2000. Bovar changed its name to Orbus Pharma in May 2003 to better reflect the activity of the company. Orbus develops generic versions of oral dosage products, which it then licenses to sales and marketing organisations which then distribute the products under their own names, ideally under five year supply agreements. The firm targets Europe and Canada as its primary markets, but had an eye on the United States as well.
Orbus' website lists four prescription products which have been completed. Amitriptyline, which was completed in the first quarter of 2009; cefuroxime axetil, which has been approved in Denmark and Canada; oxcarbazepine, which was completed in the third quarter of 2009; and moduret hydrochloride / amiloride. Another three products are listed as being under development: fluvastatin XR, metoprolol XR and a 600 mg oxcarbazepine tablet. Over the years, Orbus has signed a number of agreements with a range of companies, with a view to marketing its products in various countries. Amongst the most recent has been an agreement with Intas Pharmaceutical for worldwide rights, excluding the US and China, for Orbus' metoprolol succinate.
However, despite the progress which the firm had made in its product portfolio, Orbus suffered from financial weaknesses; in its most recent annual report, for 2008, the firm noted it had seen disappointing results in both product development timelines as well as the large amount of cash used in operations. This led to the President and CEO stepping down from his position. The new interim manager reviewed the company's business, and found weaknesses in a number of areas, leading to measures including cost reduction programmes and rationalisation of Orbus' product offering. In January 2009, the company announced that it may be up for sale, having previously announced in October 2008 that it was planning to sell its cephalosporin manufacturing facility and product line. An agreement was reached for China's Nanjing Sanhome Pharmaceutical to acquire at least 51% of Orbus' issued and outstanding common shares, and this looked to be progressing. However, in March 2010, Sanhome withdrew from the private placement. Orbus ultimately had nowhere else to turn, announcing in April 2010 that it was discontinuing its pursuit of a private placement after determining that no market was available for its common shares; neither was there any other source of financing available. The firm also decided to discontinue operations at a second site, leaving limited operations at its Markham facility.
Seeking protection under the Bankruptcy and Insolvency Act was by now the most likely way forward for the firm. The move will enable Orbus to continue with efforts to restructure its business whilst being protected from its creditors. Whilst announcing the move, Orbus also announced that it was to close its operations at its Markham facility, and would put the site up for sale. The firm does have assets, in terms of products and intellectual property. Perhaps the firm will be able to trade its way out of its current difficulties; otherwise its best hope will be to be acquired by another firm.
Ian Platts – Editor, World Generic Markets
Orbus' website lists four prescription products which have been completed. Amitriptyline, which was completed in the first quarter of 2009; cefuroxime axetil, which has been approved in Denmark and Canada; oxcarbazepine, which was completed in the third quarter of 2009; and moduret hydrochloride / amiloride. Another three products are listed as being under development: fluvastatin XR, metoprolol XR and a 600 mg oxcarbazepine tablet. Over the years, Orbus has signed a number of agreements with a range of companies, with a view to marketing its products in various countries. Amongst the most recent has been an agreement with Intas Pharmaceutical for worldwide rights, excluding the US and China, for Orbus' metoprolol succinate.
However, despite the progress which the firm had made in its product portfolio, Orbus suffered from financial weaknesses; in its most recent annual report, for 2008, the firm noted it had seen disappointing results in both product development timelines as well as the large amount of cash used in operations. This led to the President and CEO stepping down from his position. The new interim manager reviewed the company's business, and found weaknesses in a number of areas, leading to measures including cost reduction programmes and rationalisation of Orbus' product offering. In January 2009, the company announced that it may be up for sale, having previously announced in October 2008 that it was planning to sell its cephalosporin manufacturing facility and product line. An agreement was reached for China's Nanjing Sanhome Pharmaceutical to acquire at least 51% of Orbus' issued and outstanding common shares, and this looked to be progressing. However, in March 2010, Sanhome withdrew from the private placement. Orbus ultimately had nowhere else to turn, announcing in April 2010 that it was discontinuing its pursuit of a private placement after determining that no market was available for its common shares; neither was there any other source of financing available. The firm also decided to discontinue operations at a second site, leaving limited operations at its Markham facility.
Seeking protection under the Bankruptcy and Insolvency Act was by now the most likely way forward for the firm. The move will enable Orbus to continue with efforts to restructure its business whilst being protected from its creditors. Whilst announcing the move, Orbus also announced that it was to close its operations at its Markham facility, and would put the site up for sale. The firm does have assets, in terms of products and intellectual property. Perhaps the firm will be able to trade its way out of its current difficulties; otherwise its best hope will be to be acquired by another firm.
Ian Platts – Editor, World Generic Markets
Tuesday, May 25, 2010
Watson faces legal battles
Watson Pharmaceuticals has found itself at the centre of a slew of legal battles which hit the firm over a period towards the end of April 2010 and the beginning of May 2010. The challenges kicked off on 26th April 2010, when the firm confirmed that a subsidiary of Teva Pharmaceutical Industries had launched a lawsuit against Watson Laboratories after it filed an ANDA for synthetic conjugated oestrogens. Watson's ANDA, which contained a Paragraph IV certification, was for a generic version of Cenestin, used in treating postmenopausal women. The product has one patent, which expires in July 2015. The patent is listed to Duramed, Barr Pharmaceuticals' subsidiary.
Two days later, Watson confirmed that it was being sued by Pfizer and its Wyeth subsidiary in connection with Watson Laboratories' ANDA for sirolimus tablets. The product, a generic equivalent of Wyeth's Rapamune, is used in patients with renal organ transplants, and has a number of patents, the last of which expires in September 2018. Once again, Watson's ANDA contained a Paragraph IV certification, although this is only challenging the first of the patents, which expires in early 2014. Whether Watson is planning to challenge the other patents remains to be seen, but the firm noted that it believed it could be entitled to the 180-days marketing exclusivity for being the first to file.
Two days after that, on 30th April 2010, lawsuit numbers three and four were announced, with Watson confirming that its Watson Laboratories subsidiary had been sued by Abbott Laboratories and Fournier Laboratories after filing an ANDA for choline fenofibrate, a generic version of Trilipix, used in the treatment of high cholesterol. In this case, Watson is challenging the one patent listed in the FDA's Orange Book, which expires in January 2025.
On 5th May 2010 came two separate announcements of lawsuits. The first was filed by Eli Lilly, after Watson Laboratories filed an ANDA for raloxifene hydrochloride tablets, a generic version of Evista, an osteoporosis drug used in postmenopausal women. In this case, Watson is challenging three patents, which all expire in March 2017. These are not the only patents protecting the drug according to the Orange Book, but they are the last to expire; the other patents all expire in either July 2012 or March 2014. The second lawsuit to be announced on 5th May was the second in this batch to be filed by Abbott, this time in response to Watson Laboratories filing an ANDA for niacin extended release / simvastatin tablets. As with the other Abbott-related challenge, this is a product used in the treatment of high cholesterol. The product is protected by a number of patents, with expiration dates ranging between September 2013 and March 2018.
However, Watson's litigation news has not been all one way. On 7th May, Watson announced it had reached a settlement with Teva with regard to a second legal battle between the two, this time over an oral contraceptive. As with the other Teva battle, this revolved around a product which had originally been manufactured and marketed by Duramed. In this case, Watson has admitted that the patents being challenged are valid and enforceable, but in return has been granted a licence.
Of course, patent challenges are the bread and butter of generic firms, and whilst a sudden burst of lawsuits may appear to be bad news for Watson, the situation is also a sign that the firm's R&D has progressed well, enabling Watson to develop a number of new potential products for its pipeline. From the figures Watson has given, the products being challenged have a combined market value of nearly US$2.2 billion. As a generic competitor, Watson is only likely to see revenues worth much less than this, if all the challenges are successful, but nonetheless it will provide a good boost to the firm's fortunes. In the meantime unless settlements are reached out of court, the firm's lawyers will be busy in US District Courts in New Jersey, Delaware, Florida and Indiana.
Ian Platts – Editor, World Generic Markets
Two days later, Watson confirmed that it was being sued by Pfizer and its Wyeth subsidiary in connection with Watson Laboratories' ANDA for sirolimus tablets. The product, a generic equivalent of Wyeth's Rapamune, is used in patients with renal organ transplants, and has a number of patents, the last of which expires in September 2018. Once again, Watson's ANDA contained a Paragraph IV certification, although this is only challenging the first of the patents, which expires in early 2014. Whether Watson is planning to challenge the other patents remains to be seen, but the firm noted that it believed it could be entitled to the 180-days marketing exclusivity for being the first to file.
Two days after that, on 30th April 2010, lawsuit numbers three and four were announced, with Watson confirming that its Watson Laboratories subsidiary had been sued by Abbott Laboratories and Fournier Laboratories after filing an ANDA for choline fenofibrate, a generic version of Trilipix, used in the treatment of high cholesterol. In this case, Watson is challenging the one patent listed in the FDA's Orange Book, which expires in January 2025.
On 5th May 2010 came two separate announcements of lawsuits. The first was filed by Eli Lilly, after Watson Laboratories filed an ANDA for raloxifene hydrochloride tablets, a generic version of Evista, an osteoporosis drug used in postmenopausal women. In this case, Watson is challenging three patents, which all expire in March 2017. These are not the only patents protecting the drug according to the Orange Book, but they are the last to expire; the other patents all expire in either July 2012 or March 2014. The second lawsuit to be announced on 5th May was the second in this batch to be filed by Abbott, this time in response to Watson Laboratories filing an ANDA for niacin extended release / simvastatin tablets. As with the other Abbott-related challenge, this is a product used in the treatment of high cholesterol. The product is protected by a number of patents, with expiration dates ranging between September 2013 and March 2018.
However, Watson's litigation news has not been all one way. On 7th May, Watson announced it had reached a settlement with Teva with regard to a second legal battle between the two, this time over an oral contraceptive. As with the other Teva battle, this revolved around a product which had originally been manufactured and marketed by Duramed. In this case, Watson has admitted that the patents being challenged are valid and enforceable, but in return has been granted a licence.
Of course, patent challenges are the bread and butter of generic firms, and whilst a sudden burst of lawsuits may appear to be bad news for Watson, the situation is also a sign that the firm's R&D has progressed well, enabling Watson to develop a number of new potential products for its pipeline. From the figures Watson has given, the products being challenged have a combined market value of nearly US$2.2 billion. As a generic competitor, Watson is only likely to see revenues worth much less than this, if all the challenges are successful, but nonetheless it will provide a good boost to the firm's fortunes. In the meantime unless settlements are reached out of court, the firm's lawyers will be busy in US District Courts in New Jersey, Delaware, Florida and Indiana.
Ian Platts – Editor, World Generic Markets
Monday, May 10, 2010
Strides Arcolab expands US presence
India's Strides Arcolab has expanded its presence in the United States through its partnership with the Illinois-based Sagent Pharmaceuticals. The partnership was formed in late 2007 with the finalisation of an agreement to jointly develop, supply and market over 25 injectable products for the US. Under the terms of the agreement, Strides is responsible for the development and supply of the products, whilst Sagent is responsible for their marketing in the US. The first product under the agreement, azithromycin, was approved in March 2009; this was followed in September 2009 with the approval of adenosine. Approval number three was in February 2010, for labetalol hydrochloride. The agreement now appears to be gaining momentum: April 2010 saw approvals for granisetron, mesna injection and metoprolol, with a tentative approval for adenosine in new dosage strengths.
Strides' partnership with Sagent is not its only agreement covering the US, nor was it the first. Strides has made partnering a key element of its business strategy. Asides from its agreement with Sagent, Strides also has a joint venture serving the US which it formed with another Illinois-based firm, Akorn. The 50:50 joint venture was created in 2004; similarly to the partnership with Sagent, Strides is responsible for developing, manufacturing and supplying products to the joint venture, whilst Akorn is responsible for sales and marketing on behalf of the joint venture. This agreement saw 20 injectable generic drugs earmarked for development; the ANDA for the first product was filed in April 2006. By October 2006, the joint venture had filed ten ANDAs, and the two firms expanded the agreement to cover 29 products in December 2007. Akorn-Strides' first ANDA approval, for keterolac tromethamine, was approved in 2007. Since then, the joint venture has had eight products approved, with the most recent, vancomycin, gaining approval in December 2008 and being launched in April 2010.
In total, Strides claims to have partnership agreements with more than ten of the world's top 50 pharmaceutical companies in Australia, South Africa, Europe and the US. The firm has certainly been busy so far in 2010. Perhaps the most notable deal has been its collaboration with Pfizer's Established Products Business Unit, which was signed in January. Pfizer will commercialise sterile injectables supplied by two Strides joint ventures, Onco Laboratories and Onco Therapies. The other partner in the Onco joint venture is South Africa's Aspen Pharmacare. In March, Strides and Aspen announced a restructuring of their arrangements related to these two oncology joint ventures, with Aspen selling its 50% ownership to Strides for US$117 million, making Strides the sole owner. At the same time, Strides entered into another understanding with Aspen to acquire the South African firm's facility in Campos, Brazil, for a consideration of around US$75 million. Campos is a speciality injectable business; Strides' agreements with Sagent and Akorn both revolve around injectables, highlighting the importance of this market niche to Strides. Also in March, Strides made a non-binding and conditional proposal for a potential acquisition of all the shares of Ascent Pharmahealth, an Australia and Singapore-based generic, consumer skincare and OTC supplier with a customer base in Australia and Asia. Strides is currently the largest shareholder in Ascent, currently controlling around 57% of Ascent's ordinary share capital. As yet, the proposal has not produced any concrete agreements, and there is no certainty that it will. Ascent had been known as Genepharm Australasia, and in 2008, Genepharm acquired Strides' Australian and Asian businesses, ultimately providing Ascent's initial Singapore link; this deal looks to be coming full circle. Interestingly, in October 2009, Ascent entered into a distribution and services agreement with Pfizer, a deal which mirrored Strides' own agreement with Pfizer this year, and suggests the influence Strides has had over Ascent. Strides certainly seems to be developing a reach that goes beyond the company's appearance on paper.
Ian Platts – Editor, World Generic Markets
Strides' partnership with Sagent is not its only agreement covering the US, nor was it the first. Strides has made partnering a key element of its business strategy. Asides from its agreement with Sagent, Strides also has a joint venture serving the US which it formed with another Illinois-based firm, Akorn. The 50:50 joint venture was created in 2004; similarly to the partnership with Sagent, Strides is responsible for developing, manufacturing and supplying products to the joint venture, whilst Akorn is responsible for sales and marketing on behalf of the joint venture. This agreement saw 20 injectable generic drugs earmarked for development; the ANDA for the first product was filed in April 2006. By October 2006, the joint venture had filed ten ANDAs, and the two firms expanded the agreement to cover 29 products in December 2007. Akorn-Strides' first ANDA approval, for keterolac tromethamine, was approved in 2007. Since then, the joint venture has had eight products approved, with the most recent, vancomycin, gaining approval in December 2008 and being launched in April 2010.
In total, Strides claims to have partnership agreements with more than ten of the world's top 50 pharmaceutical companies in Australia, South Africa, Europe and the US. The firm has certainly been busy so far in 2010. Perhaps the most notable deal has been its collaboration with Pfizer's Established Products Business Unit, which was signed in January. Pfizer will commercialise sterile injectables supplied by two Strides joint ventures, Onco Laboratories and Onco Therapies. The other partner in the Onco joint venture is South Africa's Aspen Pharmacare. In March, Strides and Aspen announced a restructuring of their arrangements related to these two oncology joint ventures, with Aspen selling its 50% ownership to Strides for US$117 million, making Strides the sole owner. At the same time, Strides entered into another understanding with Aspen to acquire the South African firm's facility in Campos, Brazil, for a consideration of around US$75 million. Campos is a speciality injectable business; Strides' agreements with Sagent and Akorn both revolve around injectables, highlighting the importance of this market niche to Strides. Also in March, Strides made a non-binding and conditional proposal for a potential acquisition of all the shares of Ascent Pharmahealth, an Australia and Singapore-based generic, consumer skincare and OTC supplier with a customer base in Australia and Asia. Strides is currently the largest shareholder in Ascent, currently controlling around 57% of Ascent's ordinary share capital. As yet, the proposal has not produced any concrete agreements, and there is no certainty that it will. Ascent had been known as Genepharm Australasia, and in 2008, Genepharm acquired Strides' Australian and Asian businesses, ultimately providing Ascent's initial Singapore link; this deal looks to be coming full circle. Interestingly, in October 2009, Ascent entered into a distribution and services agreement with Pfizer, a deal which mirrored Strides' own agreement with Pfizer this year, and suggests the influence Strides has had over Ascent. Strides certainly seems to be developing a reach that goes beyond the company's appearance on paper.
Ian Platts – Editor, World Generic Markets
Friday, April 23, 2010
Glenmark advances in the US and Europe
March and April have proved to be busy months for the India-based firm, Glenmark Generics. On 11th April, Glenmark reported that it had settled pending patent litigation with GlaxoSmithKline regarding Glenmark's generic equivalent of the pharmaceutical giant's atovaquone and proguanil hydrochloride product, Malarone. Glenmark believes it is the first company to file an ANDA with a Paragraph IV certification for this product, and so will be entitled to the 180-days marketing exclusivity allowed under the Hatch-Waxman Act, once approval for its version is given. The patent litigation commenced in August 2009 in the US District Court for the District of Delaware; the settlement will enable Glenmark to launch its version in the third quarter of 2011, well before the expiration of the three patents in the FDA's Orange Book covering the product. All three expire on 25th November 2013, but all three have additional paediatric exclusivity periods until 25th May 2014. A paediatric dosage version of the product forms part of GlaxoSmithKline's NDA, but Glenmark is not challenging this version. Following on from its US approval for ropinirole in February 2010, on 7th April 2010, Glenmark announced that it had gained UK approval for the drug. The product, a generic equivalent of GlaxoSmithKline's Requip, is indicated for the treatment of restless legs syndrome.
Asides from its entanglements with GlaxoSmithKline, Glenmark has also had two other ANDAs approved in March and April in the US. On 26th March, its ANDA for 0.005% calcipotriene ointment was approved. The product, a generic equivalent of Leo Pharmaceuticals' Dovonex ointment, is indicated for the treatment of plaque psoriasis in adults. Leo's version is no longer marketed in the US, having been discontinued for reasons of commercial viability in April 2007. Glenmark appears to have the only marketed ointment version of the drug in the US; however, the fact that the branded version was discontinued for commercial reasons raises questions. Leo currently markets topical cream and solution variants of Dovonex; three generic versions of the topical solution variant are also marketed, by Tolmar, Hi-Tech Pharmacal and Nycomed. A few days later, on 1st April, Glenmark announced FDA approval for its 7.5 mg and 15 mg moexipril hydrochloride tablets. The product is a generic version of Schwarz Pharmaceuticals' Univasc, used in the treatment of hypertension. Branded revenues for the drug appear to be relatively small, and Glenmark's version joins long-established versions marketed by Teva Pharmaceutical Industries, Paddock Laboratories and Apotex. Glenmark noted that this approval complemented an approval for moexipril hydrochloride and hydrochlorothiazide, which was gained on 17th March 2010. On 31st March, Glenmark reported that NDAs for oxycodone hydrochloride capsules and liquid solution had been submitted by its partner, Lehigh Valley Technologies, to the FDA. The FDA has now begun reviewing the applications. Plenty of versions, both branded and generic, of oxycodone are currently marketed in the US, but these appear to all be in tablet form, which would perhaps explain why Lehigh has filed an NDA rather than an ANDA. Glenmark's partnership with Lehigh goes back to 2006, with an agreement covering two unnamed liquid generic pharmaceutical products. This was then extended some months later with an agreement covering another seven products for the US market.
However, the period has not been all plain sailing for Glenmark. On 16th March 2010, the FDA announced that it had ordered the firm to stop marketing unapproved nitroglycerin tablets. The FDA sent a warning letter requiring the tablets to be removed as part of the FDA's Unapproved Drugs Initiative, and gave Glenmark 15 days to respond with a discontinuation plan, and 90 days from the date of the letter to cease manufacturing. It is likely that Glenmark's ultimate response will be to file an ANDA for its version, in order to be able to bring it back to the market.
Ian Platts – Editor, World Generic Markets
Asides from its entanglements with GlaxoSmithKline, Glenmark has also had two other ANDAs approved in March and April in the US. On 26th March, its ANDA for 0.005% calcipotriene ointment was approved. The product, a generic equivalent of Leo Pharmaceuticals' Dovonex ointment, is indicated for the treatment of plaque psoriasis in adults. Leo's version is no longer marketed in the US, having been discontinued for reasons of commercial viability in April 2007. Glenmark appears to have the only marketed ointment version of the drug in the US; however, the fact that the branded version was discontinued for commercial reasons raises questions. Leo currently markets topical cream and solution variants of Dovonex; three generic versions of the topical solution variant are also marketed, by Tolmar, Hi-Tech Pharmacal and Nycomed. A few days later, on 1st April, Glenmark announced FDA approval for its 7.5 mg and 15 mg moexipril hydrochloride tablets. The product is a generic version of Schwarz Pharmaceuticals' Univasc, used in the treatment of hypertension. Branded revenues for the drug appear to be relatively small, and Glenmark's version joins long-established versions marketed by Teva Pharmaceutical Industries, Paddock Laboratories and Apotex. Glenmark noted that this approval complemented an approval for moexipril hydrochloride and hydrochlorothiazide, which was gained on 17th March 2010. On 31st March, Glenmark reported that NDAs for oxycodone hydrochloride capsules and liquid solution had been submitted by its partner, Lehigh Valley Technologies, to the FDA. The FDA has now begun reviewing the applications. Plenty of versions, both branded and generic, of oxycodone are currently marketed in the US, but these appear to all be in tablet form, which would perhaps explain why Lehigh has filed an NDA rather than an ANDA. Glenmark's partnership with Lehigh goes back to 2006, with an agreement covering two unnamed liquid generic pharmaceutical products. This was then extended some months later with an agreement covering another seven products for the US market.
However, the period has not been all plain sailing for Glenmark. On 16th March 2010, the FDA announced that it had ordered the firm to stop marketing unapproved nitroglycerin tablets. The FDA sent a warning letter requiring the tablets to be removed as part of the FDA's Unapproved Drugs Initiative, and gave Glenmark 15 days to respond with a discontinuation plan, and 90 days from the date of the letter to cease manufacturing. It is likely that Glenmark's ultimate response will be to file an ANDA for its version, in order to be able to bring it back to the market.
Ian Platts – Editor, World Generic Markets
Friday, April 9, 2010
AstraZeneca enters generics agreement with Torrent Pharmaceuticals
AstraZeneca has announced that it has entered into a licence and supply agreement with India's Torrent Pharmaceuticals. The firm has been vague on details, but said that the agreement would cover 18 products in nine countries, with the option to expand the agreement to cover more products and more countries. The countries are described as being emerging markets, which AstraZeneca believes will contribute around 70% of pharmaceutical industry growth in the next five years. The firm added that branded generics in these markets account for around 50% by value. The agreement will see Torrent manufacture and supply a portfolio of generics to AstraZeneca for which Torrent already has licences.
Exactly which countries AstraZeneca is referring to as emerging markets is open to debate, but Torrent claims a presence in a number of markets around the world. Included in these are African operations, including Zimbabwe, Kenya, Uganda, Nigeria, Ghana and South Africa. The firm claims it has 355 product registrations covering 14 countries in Africa, where it has seen revenues double since 1999/2000. Torrent also has made inroads into the Middle East, entering an agreement with a local producer in Saudi Arabia, and gaining approvals in Kuwait, Oman and Libya. The firm also has an eye on other markets in the Middle East, including Egypt, Syria and Jordan. Operations in Asia include a presence in Sri Lanka, Vietnam, Burma and the Philippines. Torrent also has a subsidiary in Brazil. Clearly, Torrent has developed a strategy of establishing commercial operations in the parts of the world that can be considered as emerging markets, which AstraZeneca will be well placed to exploit.
In making this agreement with Torrent, AstraZeneca is following in the footsteps of other large multinational innovator companies. Most notable in recent months has been Pfizer, which has entered into a series of agreements with Indian generic firms, similarly to AstraZeneca's tie-up with Torrent. Pfizer's agreements are the result of something of a change of heart for the firm, which until recently has been staunchly anti-generic in its outlook, despite the generally down-played existence of its Greenstone subsidiary, which produces generics. The firm has developed an Established Products Business Unit, specifically set up to exploit the international demand for generics; the shift in Pfizer's thinking perhaps underscoring the financial difficulties being faced by large innovator firms during globally economically constrained times.
Perhaps this is also the basis for AstraZeneca's similar change of heart. AstraZeneca has a stated aim to increase its penetration of emerging markets, although this is not specifically through generics. As with Pfizer, AstraZeneca's relationship with the generic industry has been somewhat fraught up until now. The firm's bitterly-fought battle to keep generic omeprazole off the global markets for as long as possible at the turn of the current century was something of a case study in aggressive legal tactics and market manipulation, and AstraZeneca was able to stave off the inevitable, and prolong its monopoly on the drug for some time past the expiration of the basic patents. The firm has not had a generics subsidiary, but has often reached settlements with generic firms in patent challenges, and in recent years has also fought generic competition by entering into authorised generic agreements, taking advantage of an issue that has split the generics industry in the United States. This latest agreement, linking the firm with a generic manufacturer, coupled with Pfizer's similar recent moves, perhaps reveals a sea-change in outlook for the branded industry.
Ian Platts – Editor, World Generic Markets
Exactly which countries AstraZeneca is referring to as emerging markets is open to debate, but Torrent claims a presence in a number of markets around the world. Included in these are African operations, including Zimbabwe, Kenya, Uganda, Nigeria, Ghana and South Africa. The firm claims it has 355 product registrations covering 14 countries in Africa, where it has seen revenues double since 1999/2000. Torrent also has made inroads into the Middle East, entering an agreement with a local producer in Saudi Arabia, and gaining approvals in Kuwait, Oman and Libya. The firm also has an eye on other markets in the Middle East, including Egypt, Syria and Jordan. Operations in Asia include a presence in Sri Lanka, Vietnam, Burma and the Philippines. Torrent also has a subsidiary in Brazil. Clearly, Torrent has developed a strategy of establishing commercial operations in the parts of the world that can be considered as emerging markets, which AstraZeneca will be well placed to exploit.
In making this agreement with Torrent, AstraZeneca is following in the footsteps of other large multinational innovator companies. Most notable in recent months has been Pfizer, which has entered into a series of agreements with Indian generic firms, similarly to AstraZeneca's tie-up with Torrent. Pfizer's agreements are the result of something of a change of heart for the firm, which until recently has been staunchly anti-generic in its outlook, despite the generally down-played existence of its Greenstone subsidiary, which produces generics. The firm has developed an Established Products Business Unit, specifically set up to exploit the international demand for generics; the shift in Pfizer's thinking perhaps underscoring the financial difficulties being faced by large innovator firms during globally economically constrained times.
Perhaps this is also the basis for AstraZeneca's similar change of heart. AstraZeneca has a stated aim to increase its penetration of emerging markets, although this is not specifically through generics. As with Pfizer, AstraZeneca's relationship with the generic industry has been somewhat fraught up until now. The firm's bitterly-fought battle to keep generic omeprazole off the global markets for as long as possible at the turn of the current century was something of a case study in aggressive legal tactics and market manipulation, and AstraZeneca was able to stave off the inevitable, and prolong its monopoly on the drug for some time past the expiration of the basic patents. The firm has not had a generics subsidiary, but has often reached settlements with generic firms in patent challenges, and in recent years has also fought generic competition by entering into authorised generic agreements, taking advantage of an issue that has split the generics industry in the United States. This latest agreement, linking the firm with a generic manufacturer, coupled with Pfizer's similar recent moves, perhaps reveals a sea-change in outlook for the branded industry.
Ian Platts – Editor, World Generic Markets
Subscribe to:
Posts (Atom)