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
Tuesday, May 25, 2010
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
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