In early May, ZymoGenetics (Nasdaq: ZGEN) reported first-quarter revenue of $5.2 million and a net loss of $33.3 million, ending the quarter with a total of $224 million in cash and investments. (I have a correction from my previous article regarding the company's recombinant human Thrombin (rhThrombin) product, which is currently under FDA review with a decision date of Oct. 18. The product will initially be developed for topical sponge application before the company pursues a topical spray-on applicator; I mistakenly wrote on May 1 that the company was developing a nasal spray formulation.)
Recent developments for rhThrombin include: training of medical liaisons to educate physicians about the product; preparing a manuscript for medical journal publication on the product's phase 3 trial results; producing inventory of the product for a fourth-quarter marketing launch; preparing for pre-approval FDA manufacturing site inspections; and launching a spray device applicator in early 2008, much sooner than originally planned. It seems pretty certain that rhThrombin will be approved by the Oct. 18 deadline, especially in light of the FDA's ruling in March that the company would not have to conduct any additional clinical trials for the drug.
Beyond rhThrombin, ZymoGenetics expects to report results from a phase 1a dose escalation study of its Hepatitis C drug candidate, PEG-interferon lambda, in the second half of this year. The company also has a cancer drug candidate (Interleukin 21) being evaluated in several early-stage clinical trials, both in combination and as monotherapy for metastatic melanoma, lymphoma, and renal (kidney) cell carcinoma.
Finally, ZymoGenetics and Merck Serono are enrolling patients in a phase 2 trial to evaluate the effectiveness of atacicept in rheumatoid arthritis patients who have not responded adequately to treatment with TNF inhibitors. Also, results from an open-label atacicept B-CLL (a specific type of chronic leukemia) trial will be presented at the ASCO annual meeting being held this year from June 1-5. Enrollment will also begin for a phase 2/3 trial in lupus patients in the second half of the year, while ongoing discussions with the FDA and the EMA work toward finalizing protocols for these trials.
With shares of ZymoGenetics currently trading near three-year lows, now may be a good time for biotech investors to pick up some shares. The company is poised to stop bleeding -- both in its stock price depreciation, and with its rhThrombin product to control bleeding during surgery. With a product that will likely be on the market by late 2007, the company can afford to put more money into research and development activities to advance its current pipeline and to discover new opportunities to pursue.
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Fool contributor Mike Havrilla, R.Ph., B.S., Pharm.D., is a Rite Aid pharmacist who lives, writes, works, and enjoys running on the streets and trails in the small Pennsylvania town of Portage. He invites your comments and feedback. Learn from the collective stock-rating wisdom of Foolish investors and see his picks and pans at the free Motley Fool CAPS community home page. Mike does not have a position in any company mentioned in this article. The Fool has a disclosure policy.