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

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