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Myriad Pharmaceuticals Acquires Novel HIV Drug, Bevirimat, a First-in-Class Maturation Inhibitor, Represents a New Class of HIV Drugs
 
 
  Wed., Jan. 21, 2009
 
SALT LAKE CITY, UT - Myriad Pharmaceuticals, Inc. today announced that it has acquired all rights to bevirimat from Panacos Pharmaceuticals, Inc. (NASDAQ: PANC) for an upfront payment of $7M.
 
The upfront payment represents the total payment for bevirimat and will be expensed by Myriad Genetics, Inc. (NASDAQ: MYGN), the parent company of Myriad Pharmaceuticals, during its third fiscal quarter ending March 31, 2009. Myriad Pharmaceuticals has no future milestone or royalty obligations to Panacos. The assets include all patents and patent applications related to the compound, all product inventories, ownership of all clinical data and all rights to regulatory filings. Myriad will assume control of all clinical and commercial development going forward.
 
"Based on the progress that Panacos has made with bevirimat and the results to date, Myriad Pharmaceuticals believes that bevirimat has great potential for the treatment of patients infected with HIV," said Adrian Hobden Ph.D., President of Myriad Pharmaceuticals, Inc. "We will work diligently to advance this compound through clinical development so that it can become a valuable addition to the drugs currently available to treat this terrible disease."
 
About Bevirimat
 
Bevirimat has demonstrated potent activity against a broad range of HIV strains, and laboratory studies have shown bevirimat to be an inhibitor of HIV isolates that are resistant to currently approved HIV drugs. Nearly 650 subjects, including over 100 HIV-infected patients, have been studied in clinical trials. Results from these trials have shown bevirimat to be well tolerated and have demonstrated significant and clinically relevant reductions in viral load in a subset of HIV-infected patients. Epidemiology data show that this subset represents a majority of HIV infected patients. Bevirimat is currently in Phase 2b clinical studies using a new tablet formulation that has an oral bioavailability and pharmacokinetic profile comparable to the previous solution formulation.
 
Myriad Pharmaceuticals, Inc.
 
Myriad Pharmaceuticals, Inc. is currently a wholly owned subsidiary of Myriad Genetics, Inc. (NASDAQ: MYGN). Myriad Pharmaceuticals anticipates becoming an independent, publically-traded company by the end of the second calendar quarter of 2009.
 

Myriad Snares HIV Drug in $7M Deal with Panacos
 
BioWorld Today - Jan. 22, 2009
 
Deals Roundup
 
Myriad Pharmaceuticals Inc. got a late midstage HIV drug and Panacos Pharmaceuticals Inc. got a bloody nose from Wall Street Wednesday when the latter sold its bevirimat compound to the former for $7 million.
 
Panacos took a 55.6 percent stock hit on the news, but the $7 million up-front payment - the deal does not include any royalties or other future payments - adds badly needed funds to the struggling firm's coffers, which as of Dec. 8, 2008, held only $4.7 million in cash and cash equivalents.
 
Shares of Panacos (NASDAQ:PANC) fell 10 cents, to close at 8 cents.
 
While Panacos has other compounds in its pipeline, bevirimat, in Phase IIb testing, was the only one in the clinic. In October, the Watertown, Mass.-based company reported that bevirimat Study 204 met its primary objective by demonstrating bevirimat plasma levels in HIV-positive patients to be in a target range for virologic reduction. After 14 days of bevirimat treatment given twice daily at doses of 200 mg or 300 mg, 100 percent of 32 treatment-naive and treatment-experienced patients in Study 204 had bevirimat plasma concentrations well above the previously identified minimum target of 20I 1/4g/mL. In addition, bevirimat's safety profile was comparable to earlier studies where it had been indistinguishable from placebo.
 
That study was intended to collect data to optimize the bevirimat tablet dose for future Phase II, as well as Phase III registration trials.
 
Panacos President and CEO Alan W. Dunton described the deal as necessary "to manage capital resources in the current market environment." Myriad Pharmaceuticals, he noted, has the development infrastructure and financial resources to move bevirimat into late-stage testing and through FDA review. "We now turn our full attention to our other promising HIV programs and seeking additional financing and partnerships to continue the development of our spectrum of HIV programs," Dunton said in a statement. "We retain a significant intellectual property estate, including all of the company's second- and third-generation maturation inhibitor compounds, the company's novel oral fusion inhibitor program and our proprietary assays."
 
The company has two preclinical HIV programs, one on a next-generation HIV maturation and one in fusion, and the second a research program for a third-generation HIV maturation inhibitor.
 
Bevirimat may become the star of Myriad Pharmaceuticals in June when its parent company, Myriad Genetics Inc., spins off the pharmaceutical unit into a new company. Bevirimat will join three other compounds in the pharmaceutical pipeline, the most advanced of which is MPC-9055, a small-molecule candidate for the oral treatment of HIV-1. It has completed a Phase I dose-escalation trial in healthy volunteers and is proceeding to a Phase IIa, multiple-ascending dose trial in treatment-naive HIV-infected individuals. The Salt Lake City-based company also has two preclinical HIV candidates.
 
Charles C. Duncan, analyst with JMP Securities Inc., wrote in a research note that the acquisition "further bulks up the product portfolio for the pharmaceutical unit . . . and makes it more attractive for potential investors upon spin-off. The development does not impact the management's commitment for the spin-off, and the progress toward the targeted timeline remains on track. In our view, the acquisition demonstrated a good strategic move by the management of Myriad Pharmaceuticals as it broadens the HIV franchise of its drug development pipeline with relatively few cash investments."
 
Shares of Myriad Genetics (NASDAQ:MYGN) rose $2 to close at $72.23.
 
MPC-9055
 
MPC-9055 is a novel, potent, small-molecule drug candidate designed by Myriad Pharmaceuticals for the oral treatment of human immunodeficiency virus 1 (HIV-1) infection. MPC-9055 has successfully completed dose escalation in a Phase 1 human clinical trial in healthy volunteers, and is proceeding to a Phase 2a, multiple ascending dose trial in treatment-naive HIV-infected individuals.
 
About MPC-9055
 
MPC-9055 is a potent small-molecule maturation inhibitor being developed for the oral treatment of HIV-1 infection. MPC-9055 targets a unique cleavage event in the HIV life cycle, inhibiting the processing of a Capsid-Spacer 1 intermediate of the Gag protein. This results in a noninfectious virion, and prevents subsequent rounds of HIV infection. MPC-9055 does not inhibit HIV protease. As a viral maturation inhibitor, MPC-9055 has the potential to be the first drug in a new class of agents for the treatment of HIV-1 infection. The Phase 1 trial was designed as a single ascending dose study to assess the safety, tolerability and pharmacokinetic parameters of MPC-9055 in healthy volunteers. The overall safety profile was favorable with no serious adverse events or clinically significant changes in laboratory values or electrocardiograms. The observed pharmacokinetic profile supports continued development. MPC-9055 has good oral bioavailability and the study demonstrated enhanced absorption of MPC-9055 when taken with food. This is an additional positive for the drug candidate since that is the preferred option to dosing on an empty stomach.
 
MPC-9055 has been tested extensively in preclinical in vitro and in vivo studies to establish antiviral activity and assess safety. It demonstrated potent antiviral activity, with an average HIV IC 50 value of 10 nanomolar and an approximate 1,000-fold in vitro therapeutic index. MPC-9055 was also shown to be active against viral strains that are resistant to the currently marketed anti-HIV drugs, including nucleoside reverse transcriptase inhibitors such as AZT, non-nucleoside reverse transcriptase inhibitors such as Efavirenz, and protease inhibitors such as Ritonavir. MPC-9055 has been well-tolerated and exhibits a favorable safety profile in a variety of preclinical studies. Myriad's anti-viral drug discovery program began with the discovery of the interaction between the HIV Gag protein and the human host protein, TSG101, in the viral budding/maturation pathway of HIV. This research was first published on October 5, 2001 [1], and expanded upon in September, 2003 [2]. Both articles were featured as the cover article in the journal Cell. Myriad scientists have made subsequent discoveries regarding the biology of HIV viral particle maturation, viral fusion with host cells and intra-cellular events in the life cycle of HIV which has enabled Myriad to identify additional novel targets which may inhibit HIV infection.
 
 
 
 
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