As expected , the euphoria about Big Pharma's $2 billion acquisition of Inhibitex (INHX) +13.83 (140.12%) caused other companies in the space to rise on Monday-- a trend which some observers feel may continue to play out in the short term.
We told our subscribers that Hepatitis C treatments represent a big opportunity for drugmakers and all the acquisitions in the Hep-C space lately have speculators looking to see what other biotech firms without existing ties or big pharma partnerships for their HCV programs could become the next takeover candidate. A look around the landscape and found a few interesting (and not so interesting) development stories in the space.
Array BioPharma Inc (ARRY) has RG7227 in Phase II clinical trials. This is a HCV NS3/4 protease inhibitor and is a potent and selective small molecule inhibitor of the Hepatitis C virus. RG7227 is being developed as an oral formulation for the treatment of chronic hepatitis C.
BioCryst Pharmaceuticals (BCRX) continues to advance its leading pre-clinical program: BCX5191, a potent and selective nucleoside analog targeting RNA polymerase for the potential treatment of hepatitis C assets towards IND filings during the second half of 2012.
EpiCept Corp (OTC:EPCT) has a pre-clinical program of its own studying F573. In July 07, 2011 Epicept’s affiliate, GNI Ltd. announced that its fully owned subsidiary in China, Shanghai Genomics had filed an IND of F573 with the Shanghai FDA. F573 is a di-peptide small molecule compound with potent inhibitory effects on a class of enzymes critical for cell death and inflammatory response. F573 is being developed for the treatment of viral hepatitis.
Back in mid-2008, GNI Ltd, and EpiCept Corporation announced that they have reached agreement to develop a new therapeutic drug, EP1013, in Asia, Australia, and New Zealand, for late-stage viral infection-induced hepatitis. EpiCept will retain the rights in the rest of the world.
Idenix Pharmaceuticals (IDIX) has shares gained 37% on Monday after investors took a closer look at the various drugs in their pipeline focused on agents for advance treatment of Hepatitis C. The company has an ongoing HCV development and discovery program building a critical mass of candidates in three different classes of drugs, including: nucleoside polymerase inhibitors, non-nucleoside polymerase inhibitors and protease inhibitors. Its pipeline products include: IDX375, a lead clinical candidate from its HCV non-nucleoside polymerase inhibitor discovery program, IDX136, a novel macrocyclic HCV protease inhibitor being developed as oral formulation for the treatment of Hepatitis C, IDX316, a novel macrocyclic HCV protease inhibitor being developed as oral formulation for the treatment of Hepatitis C. etc. The company co-developed and co-launched the licensed hepatitis B drug candidate, telbivudine. The company has collaborations with Novartis Pharma AG, and GlaxoSmithKline, but those affiliations are not for any of the Hepatitis C drugs. We did a more detailed write up on the firm back in early December when shares looked "overbought." The price did pull back a bit and consolidation has followed.
Although its clinical status is currently unknown, even Hemispherx Biopharma Inc (HEB) had a product for HCV. It’s their now famous Alferon N--whose anti viral activity, immunomodulatory action and anti proliferative action inhibits viral transcription-- was, at one point, being developed as an injection for the treatment of hepatitis C, but a program update has not been given for some time. Alpha interferon is a protein that occurs naturally in the body and helps improve the body's natural defenses by preparing it to fight viruses and attack and slow the growth of tumors. Pass.
A pink sheet penny stock called Immtech Pharmaceuticals Inc (OTC:IMMP) claims that their mission is to develop and commercialize new treatments for infectious diseases and other disorders with significant unmet needs. It was founded in 1984 as Immtech International, Inc. and changed its name to Immtech Pharmaceuticals, Inc. in March 2006. Their drug discovery program has thus far only generated a pre-clinical drug candidates for treating hepatitis C. From what we can see, the “Anti Hepatitis C compound” belongs to an expanding class of compounds that has demonstrated activity against a related surrogate virus, bovine viral diarrhea virus. Pass.
InterMune (ITMN) shares gained 10.5% on Monday as more speculators looked at the firm engaged in the development of their next-generation HCV protease inhibitor research program which is currently at the Pre-Clinical level. The company had been very active in this space but discontinued several other programs which had partners like Hoffman-La Roche Inc, Amgen, PDL BioPharma and Valeant Pharmaceuticals among others.
At one point, Isis Pharmaceuticals Inc. (ISIS) did have a product named MK0608 which was being developed for the treatment of hepatitis C virus infection. As of October 18, 2009, that nucleoside inhibitor of NS5B hepatitis C virus (HCV) RNA-dependent RNA polymerase was reportedly in Phase I clinical trials. But we found no further updates or data.
Interestingly, in a related note -- Regulus Therapeutics, which leverages the oligonucleotide drug discovery and development expertise of its founding companies, Alnylam Pharmaceuticals (ALNY) and Isis, is developing innovative medicines targeting microRNAs. They are advancing microRNA therapeutics toward clinical development in several areas, including fibrosis, hepatitis C, immuno-inflammatory diseases, metabolic diseases and oncology. In February 2010, Regulus and GlaxoSmithKline entered into a new collaboration to develop and commercialize microRNA therapeutics targeting microRNA-122 for the treatment of hepatitis C infection.
All that aside, chances are nothing is likely cooking at ISIS in regards to this, or why would insiders be selling as many shares as they did in December?
Nanoviricides (NNVC) disclosed in a February 2011 10-Q filing that they have begun the early stages of a plan to develop nanoviricides against Hepatitis C. As we understand it, their product, HepCCide-I is a targeted nanoviricide, which attacks, neutralizes and disables the hepatitis C virus. Still, the program is very early on.
Peregrine Pharmaceuticals’ (PPHM) gapped at the open, trading over 8% higher, but it was not able to hold on to the early gains, closing up only 1.10% for the day despite it's low pricing. The firm's pipeline includes Bavituximab Anti-Viral, a monoclonal antibody indicated for the treatment of Hepatitis C and Hepatitis C Coinfected with HIV/AIDS. In late December, Peregrine provided an update from its randomized Phase II bavituximab study in patients infected with genotype-1 chronic hepatitis C virus (HCV). The goals of the randomized study are to determine if bavituximab plus ribavirin has a better safety profile as compared to interferon plus ribavirin, to confirm that the combination of bavituximab and ribavirin has antiviral activity defined as 12 week early virologic response (EVR) 1 and to compare antiviral activity of peg-interferon plus ribavirin versus bavituximab plus ribavirin. The BioMedReports FDA Calendar and Clinical Trials Tracker shows that the company plans to present full phase II results from the study at a medical conference sometime in 2012.
If I didn’t have a lot of money to jump in to one of the pricier stocks but still sought to have some skin in the Hepatitis C frenzy, this might be one worth considering since it’s a big board trade play with forward looking news and its currently trading 70% from its 52-Wk High ($ 3.10). In addition, there are currently over 4 million shares short in the stock and any good news will send those shorts scrambling to cover-- pushing the stock price higher quickly. In fact, that good news could come in the first half of 2012, as the company previously said that they look forward to evaluating and reporting Bavituximab interim data from an earlier completed randomized Phase II trial in front-line NSCLC and as they await unblinding data from this second-line NSCLC trial in the first half of 2012. In their prior Phase II trials, they have seen encouraging tumor response data, which have correlated with promising survival for patients treated with bavituximab in combination with chemotherapy.
Of course, we mentioned Achillion Pharmaceuticals, Inc. (ACHN) whose shares jumped nearly 23% on Monday. I told our premium subscribers prior to the move that I wanted to jump on a stronger horse in the race, this would be one I'd consider. Just last week the firm said their small molecule drug to combat this most challenging infectious diseases received fast track designation, allowing for a quicker review by U.S. regulators. The treatment, labeled ACH-1625, is in mid-stage clinical testing for the treatment of chronic hepatitis C virus (HCV). The designation allows drug developers to submit their applications to the Food and Drug Administration piece by piece instead of having to file all the paperwork at once.
Achillion Pharmaceuticals’ product portfolio include: four clinical candidates for the treatment of chronic hepatitis C infection which include ACH-1625 (the once-daily NS3 protease inhibitor); ACH-2684, a pan-genotypic inhibitor of HCV NS3 protease with pico-molar potency; ACH -2928, a pico-molar potent inhibitor of HCV NS5A that demonstrates pan-genotypic activity; and ACH-1095, a candidate that specifically recognizes the HCV target, NS4A. The company is also developing ACH-702 for the treatment of serious nosocomial bacterial infections.
Our calendar shows a couple of early pipeline development catalysts for the stock, including one for ACH-3102, which is currently undergoing IND-enabling studies and is expected to be advanced into clinical trials during the first half of 2012. The firm re-affirmed those expectations in a news release last December.
Earlier this year, the FDA approved two pills that offered the first new breakthrough treatments for the liver disease in 20 years. The Vertex Pharmaceuticals Inc. hepatitis C pill Incivek rang up about $420 million in this year's third quarter. Another pill, Merck & Co.'s Victrelis had $31 million in sales.