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Jul 15, 2008 -- Lev Pharmaceuticals, Inc. (OTC BB: LEVP | Quote | Chart | News | PowerRating) and ViroPharma Incorporated today announced that the companies have signed a definitive merger agreement under which ViroPharma will acquire Lev, a biopharmaceutical company focused on developing and commercializing therapeutic products for the treatment of inflammatory diseases, for $442.9 million of upfront consideration, or $2.75 per Lev share, comprised of $2.25 per share in cash and $0.50 per share in ViroPharma common stock (subject to a collar). Contingent consideration of up to $1.00 per share may be paid on achievement of certain regulatory and commercial milestones. The transaction with a potential net aggregate value of up to $617.5 million has been unanimously approved by the boards of directors of both companies. The companies expect the transaction to be completed by the end of 2008. In addition, concurrently with the execution of the merger agreement, ViroPharma purchased $20 million of Lev common stock. The acquisition of Lev Pharmaceuticals further enhances ViroPharma's pipeline with Cinryze(TM) (C1 inhibitor (human)), which is currently under regulatory review for approval by the U.S. Food and Drug Administration as a replacement therapy for patients with hereditary angioedema (HAE), also known as C1 esterase inhibitor (C1-INH) deficiency. Clinical studies have shown that prophylactic C1 inhibitor replacement therapy with Cinryze can significantly reduce the severity, duration and frequency of HAE attacks. "This transaction is consistent with ViroPharma's stated objective of broadening our portfolio of therapies for serious life-threatening conditions in selected specialty markets," commented Vincent Milano, ViroPharma's president and chief executive officer. "Lev's orphan drug Cinryze(TM) is a life-saving therapy treating a very dangerous disease. This opportunity provides a clear strategic fit with ViroPharma: Cinryze targets a market that is addressable with modest additional infrastructure and further serves patients suffering from a disease with few treatment options. We are very pleased to add the expertise of Lev to our organization, and Cinryze to our growing portfolio of options for underserved patient populations with critical and urgent needs."
Jul 15, 2008 -- DOR BioPharma, Inc. (OTC BB: DORB), a late-stage biopharmaceutical company developing products to treat the life-threatening side effects of cancer treatments, serious gastrointestinal diseases and vaccines against certain bioterrorism agents, announced today that it has executed a definitive collaborative agreement with IDIS Limited, for the supply and distribution within the European Union of the Company's investigational drug orBec (oral beclomethasone dipropionate) for the treatment of gastrointestinal Graft-versus-Host disease via a named patient program. IDIS is the leading specialist in the management of NPPs in Europe. An NPP is a compassionate use drug supply program under which medical practitioners can legally supply investigational drugs to qualifying patients. Under an NPP, investigational drugs can be administered to patients who are suffering from serious illnesses until the drug is approved by the European Medicines Evaluation Agency or a national health authority. The NPP will allow DOR to provide a treatment option to patients with GI GVHD, an unmet medical need. The GI GVHD market in Europe is believed to be about 60% of the more than 10,000 allogeneic bone marrow/stem cell transplantations occurring there annually. "We are very pleased to partner with IDIS to make orBec available to GI GVHD patients in Europe," stated Christopher J. Schaber, PhD, President and CEO of DOR BioPharma. "We remain steadfast in our mission to deliver orBec to patients who desperately need a therapeutic option. Based on its reach and focus, IDIS is clearly the optimal choice as a partner for implementing the NPP in Europe. We anticipate initiating this program soon knowing there is potential to generate revenues that will help to support the confirmatory orBec Phase 3 clinical trial. We have already received inquiries from clinicians in Europe interested in the availability of orBec for their patients." John Lagus, Vice President of Business Development for IDIS, said, "We are delighted to be working with DOR to provide patients with GI GVHD access to orBec , so they can benefit from DOR's innovative therapy. IDIS will work in close partnership with DOR to manage NPP requests in a way that is reliable and responsible while ensuring that all the regulatory obligations are met."
Jul 15, 2008 -- Alfacell Corporation (NASDAQ: ACEL | Quote | Chart | News | PowerRating) today announced that it has entered into a distribution agreement with Megapharm Ltd., a leading pharmaceutical company in Israel, for the commercialization of ONCONASE (ranpirnase) in Israel. ONCONASE, the company's lead drug candidate, recently completed an international confirmatory Phase IIIb clinical trial for unresectable malignant mesothelioma. Under the agreement, Alfacell has granted Megapharm exclusive rights in the defined territory for the marketing, sales and distribution of ONCONASE. Alfacell will receive 50% of all sales in the territory. In addition, Alfacell will manufacture and supply the product to Megapharm, while Megapharm will be responsible for all activities and costs related to regulatory filings and commercial activities in the territory. Miron Drucker, CEO and founder of Megapharm, said, "Having been interested observers in the development of ONCONASE, a first-in-class anti-cancer agent, we are proud to include this unique product in our oncology portfolio. We believe that ONCONASE will prove to be a promising new treatment option for patients suffering from mesothelioma." Kuslima Shogen, chief executive officer of Alfacell, stated, "We are very pleased to add Megapharm to our growing list of important regional partners for ONCONASE. Megapharm's role as a leader in biotechnology marketing in Israel provides Alfacell with an ideal partner to maximize the potential of ONCONASE in this region. We look forward to a successful collaboration with Megapharm."
Jul 15, 2008 -- Dyax Corp. (NASDAQ: DYAX | Quote | Chart | News | PowerRating) announced today that the Company has entered into an exclusive negotiation period ending on September 30, 2008 with Dompe Farmaceutici S.p.A. ("Dompe") for a European license to DX-88 in angioedema indications, including hereditary angioedema (HAE), for which the Company recently completed its second Phase 3 trial. As a condition for the exclusive negotiation rights, Dompe entered into a Securities Sale Agreement with Dyax to purchase 2,008,032 million shares of Dyax common stock in a private placement at $4.98 per share, which represents a 57% premium over the closing price on July 10, 2008. The offering, which represents a total investment of $10 million, is expected to close on July 17, 2008. "We look forward to finalizing a partnership with Dompe for DX-88 in angioedema indications, and believe that their regulatory and commercial capabilities in Europe could add significantly to the DX-88 franchise worldwide," commented Henry E. Blair, Chairman, President and Chief Executive Officer of Dyax. "Dompe's premium, unconditional investment in Dyax highlights the value potential of the DX-88 franchise as well as our proprietary phage display discovery technology. This agreement, if finalized, will be another step towards the completion of our DX-88 global strategy, which also includes a partnership with Cubist Pharmaceuticals for surgical indications, and our own commercial infrastructure for hereditary angioedema within the U.S." Sergio Dompe, President of Dompe Farmaceutici S.p.A, stated, "We are very pleased to enter into this exclusive negotiation period with Dyax for a European license to DX-88 in angioedema indications, which represent a strategic opportunity for Dompe. This agreement falls within a broader strategy aimed at the expansion of the Dompe Group at the international level, with a focus on developing its expertise in the area of rare diseases. While the discovery of rare diseases and their more accurate diagnosis is steadily increasing, there are still very few drugs available for their treatment. Through this investment with Dyax, the Dompe Group provides its contribution to the research and development of therapeutic solutions for unmet medical needs in the orphan drug arena."
Market Wrap for July 15th, 2008
Tuesday was an extremely busy and volatile session as market participants digested testimony from Fed Chairman Bernanke, several economic and earnings reports, and a plunge in crude oil prices. With regard to Bernanke's testimony before the Senate Banking Committee, the Fed chairman mostly reiterated previous views that he or other Fed officials have already expressed. Bernanke noted significant risks to downside growth, and "intensified" inflation risks. In turn, the Fed raised its 2008 inflation forecast. In heavy trading, the stock market fell 2.2% shortly after the open, rallied to a 0.5% gain in an afternoon surge and then settled with a loss of 1.1% following a late-session sell off. Financials were at the forefront of this session's decline and volatile action. The sector slumped to a 5.7% loss shortly after the opening bell on continued concerns regarding Fannie Mae (FNM 7.03, -2.70) and Freddie Mac (FRE 5.29, -1.82), a tepid response to US Bancorp's (USB 22.70, -0.63) earnings and an Oppenheimer downgrade of Wachovia (WB 9.11, -0.73). There did not appear to be a specific cause for the tumble in crude prices, which occurred during Bernanke's testimony. Oil prices settled the day down 4.5% at $138.62 (prices fell as much as 6.4% after being up 1.1% early in the session). The stock market responded positively to the drop in crude prices, although some enthusiasm faded late in the session. Four sectors ended the session with a gain. Health care led the way with a 1.3% advance, aided by positive earnings and outlook from Johnson & Johnson (JNJ 67.67, +1.26). The energy sector posted the largest decline of 4.2%, coming under selling pressure as crude prices sank. On the economic front, the June Producer Price Index (PPI) -- an inflation reading -- came in mixed. Total June PPI rose above expectations as higher energy and food prices drove up costs, while core PPI, which excludes food and energy prices, increased by a lower than expected amount. June retail sales were disappointing, falling short of expectations. However, the results do not alter our view that real GDP should increase by at least 2.5% in the second quarter. Specifically, retail sales rose 0.1% (consensus +0.4%), retail sales ex-autos rose 0.8% (consensus +0.9%). A larger portion of the ex-autos number is due to the 4.6% increase in gasoline sales on an adjusted basis. Excluding gas, retail sales were down 0.5% from the prior month.
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