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Shire, an Irish speciality pharma and rare diseases drug maker, today announced that it would purchase Connecticut-based Advanced BioHealing (AB) for $750 million in an all cash deal. 

The main reason for the deal was AB’s Dermograft, a regenerative bio-engineered skin substitute used for the treatment of diabetic foot ulcers (DFU). Dermagraft currently has roughly a 5 percent share of the potential $3 billion slow-healing DFU market, approximately $146 million in US sales last year, and Shire says the potential for growth in the DFU market is considerable. Also, AB had finished enrolling patients into multinational trials to investigate Dermagraft for the treatment of venous leg ulcers. If all goes as planned, a regulatory filling in the USA for the new indication is planned for the first quarter of 2012.

Shire tendered its offer to purchase Advanced BioHealing one day before the company was to launch an initial public offering of 13.4 million shares priced from $14 to $16. The IPO would have raised over $200 million and the company would have been valued at around $630 million. The deal was a strategic move for Shire that wants to expand its product offerings in the speciality pharma sector. It isn’t clear whether the acquisition will result in layoffs at AB. Unfortunately, all cash transaction typically do not bode well for the company this is being acquired.

In other news, Takeda, after denying reports earlier in the week that it intended to purchase Nycomed for $12.0 billion is expected to announce the deal today.

Until next time...

Good Luck and Good Job Hunting!!!!!!

Addendum: At the press conference this afternoon, Takeda tersely stated that it had not agree to purchase Switzerland's Nycomed. Stay tuned for the next installment of the saga!

Addendum to the Addendum: Takeda Pharmaceuticals and Nycomed  jointly announced today that Takeda has reached an agreement with the shareholders of Nycomed in which Takeda will acquire the Zurich-headquartered company for $13.6 billion ( 9.6 billion Euro) on a cash-free, debt-free basis. The boards of directors of each company unanimously approved the transaction which is expected to be completed within 90 to 120 days, making it a wholly owned subsidiary of Takeda, subject to antitrust clearance. The purchase would exclude Nycomed's U.S. dermatology business.

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Since I don’t have a magic mirror, I can only go on what I read in the Internet. And, it appears that Roche may be the most ambitious pharma company of them all; at least by 2013. According to a post on PharmLive, “Roche’s late-stage pipeline is progressing well with potentially ten regulatory submissions of new molecular entities until the end of 2013.”

So what drugs make up this rather full pipeline?

1. T-DM1 (trastuzumab-DM1)-antibody-drug conjugate for Her-2 positive breast cancer
2. Pertuzumab/trastuzumab (Herceptin)-monoclonal antibody cocktail to treat Her-2
3. positive breast cancer
4. MetMab-a unique monovalent monoclonal antibody for non-small cell lung cancer
5. GA101/RG7159-the first glycoengineered type II humanized anti-CD20 monoclonal for relapsed/refractory progress non-Hodgkins lymphoma
6. RG7204-anti-BRAF protein monoclonal antibody for BRAF-mutation-positive metastatic lung cancer
7. RG1678-first-in-class glycine reuptake inhibitor that normalizes glutamate neurotransmission for schizophrenia and other psychiatric indications
8. RG1594 (ocrelizumab)-humanized anti-CD20 monoclonal for multiple sclerosis

Not surprisingly, many of these molecules were developed at Genentech, the world’s largest biotechnology company that was purchased by Roche almost two years ago.

Until next time...

Good Luck and Good Job Hunting!!!!

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A rare or orphan disease is defined in the US as one that affects fewer than 200,000 at any given time. It is estimated that there are 6000 to 8000 rare diseases in the world today. Because the number of patients afflicted with orphan diseases is so small, drug companies have historically been reluctant to invest money to discover and develop new treatments for them. The dearth of treatments for rare diseases induced Congress to pass the Orphan Drug Act in 1983 which provided market exclusivity, tax breaks and incentives and regulatory help for companies to development new drugs for orphan disease indications.

While many current blockbuster drugs including recombinant human insulin, growth hormone and erythropoietin originally garnered regulatory approval after receiving orphan status in the late 1980s, most big pharma and biotechnology companies (except Genzyme) largely abandoned orphan drug development until recently. The renewed interest in orphan drug development has been primarily driven by the demise of big pharma’s blockbuster business model that began in the early 2000s. The search for new, non-blockbuster drugs and fresh markets is what induced Pfizer, the world’s largest pharmaceutical company, to recently inked a multimillion dollar deal with Protalix Biotherapeutics, a small biopharmaceutical company developing a new treatment for Gaucher disease—an orphan indication.

Because of renewed interest and the ever increasing need for new orphan drugs, the FDA’s Office of Orphan Products Development is offering an Orphan Drug Designation Workshop that will provide a unique opportunity for all potential drug sponsors—including biotechnology companies, pharmaceutical firms and academic institutions—to learn about the application process for orphan drug designation.

The National Organization for Rare Disorders (NORD) is a co-sponsor of the workshops, which will take place on February 25-26 at Keck Graduate Institute and August 3-4 at the University of Minnesota.

Participants are encouraged to bring specific product proposals for at least one candidate orphan drug that holds promise for the treatment of a rare disease. A significant portion of the workshop will be dedicated to preparing applications, including one-on-one guidance sessions with FDA staff members. FDA will keep product and disease information confidential.

Final applications can be submitted to the FDA at the close of each workshop. For information or to register:

FDA Workshop Brochure
Registration for the February Workshop

Finally, February 28^th is Rare Disease Day. The event is sponsored by the EURODIS a European advocacy group that promotes awareness and research for rare diseases. NORD and Discovery Health are also sponsoring the day.

Until next time....

Good Luck and Good Job Hunting!!!!!!!!!

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