Biotech News- 2/9/15 to 2/13/15

Biotech Tuesday TalkAchillion Pharmaceuticals (ACHN)

Shares of Achillion gained 7% on 2/9/15 last week when it had announced that it had achieved a 100% SVR12 in a phase 2 trial treating patients with the genotype 1 version of the Hepatitis C virus — HCV. The trial tested for the primary objective of patients being able to achieve a 100% SVR — Sustained Viral Response — in a 12 week period. All 12 patients enrolled in the study were able to achieve that 100% SVR in a 6-week period marking a fast reduction treatment for these patients with the genotype 1 HCV. The trial used a combination of 50mg of Achllion’s ACH-3102 together with 400 mg of Sovaldi produced by Gilead Sciences (GILD). One thing to note is that the study was a ribavirin free treatment regimen which is good because ribavirin is very toxic and has many adverse effects. Achillion achieving such a great response rate for these patients in a 6 week period is encouraging enough but now the company plans to attempt to leverage its other assets ACH-3102, ACH-3422, and sovaprevir to reduce treatment time down to 4 weeks. If it can pull that off then it has a chance to become a powerhouse in the Hepatitis C space if and when its drugs are ultimately approved.

Regulus Therapeutics (RGLS)

Shares of Regulus Therapeutics remained down 7% on 2/9/15 when it had announced final results from its phase 1 trial testing RG-101 as a single-shot injection treatment for patients with all genotypes of the Hepatitis C virus. The trial even tested patients who had relapsed from interferon — a bundle of proteins known as cytokines that help  trigger the immune system and stop viral replication. The problem with interferon is that it produces a lot of undue toxicity to the patient’s body. When higher doses of interferon are given to patients there is a possibility to get severe side effects similar to that of chemotherapeutic agents to eradicate cancerous cells. Such side effects include: Nausea, vomiting, hair loss, allergic reaction and many others.

There were two different types of doses being tested using the RG-101 single-shot injection for Hepatitis C. One group received 2 mg/kg and the other group received 4 mg/kg. The 2 mg/kg dose group achieved a BLOQ — Below the limit of quantification for Hep C virus —  with 2 patients out of the 14 patients treated at day 57. Although in the 4 mg/kg dose group their were 9 patients out of 14 patients that were BLOQ of HCV RNA levels. Both trials will be followed for 6 months to one year to determine further reductions of HCV RNA levels as time progresses. Regulus is doing this to determine the full extent of efficacy that RG-101 can achieve as a single shot cure for HCV. Whether or not Regulus achieves a single-shot cure will not make or break the company. That is because the company may also be able to combine its RG-101 treatment with other oral HCV treatments that may produce increased efficacy.

Pfizer Inc. (PFE)

Pfizer announced on Friday 2/13/15 that the FDA has accepted the company’s New Drug Application (NDA) for ALO-02 — a combination of oxycodone hydrochloride and naltrexone hydrochloride — that is used to treat non-cancerous types of pain. The main improvement of this formulation over other opioids currently marketed is that it was specifically built to be an abuse deterrent type of drug. Pfizer achieved this function by first making the capsules to be extended-release capsules. This means that the drug is released in the body over a long period of time and not immediately thus reducing the risk of the oxycodone pill being abused by the user. Secondly the pill is designed in a way where if the user takes the pill as prescribed orally then the oxycodone hydrochloride does its job properly like it is supposed to, but if the user attempts to crush the pill then the naltrexone hydrochloride counteracts the effects of the oxycodone hydrocloride .This mechanism of action blocks the ability to abuse AL-02 by attempting to crush it then inhale it or take it intravenously through the blood stream. Pfizer has already conducted two phase 3 trials to prove the efficacy of the compound and an additional three studies already tested the ability for AL-02 to be an abuse deterrent formulation — ADF.

Abbvie (ABBV)

Abbvie announced on Thursday 2/12/15 that it had submitted a New Drug Application in Japan for its all oral regimen that is free of both Ribavirin and Interferon — two previous standard of care drugs for Hepatitis C infection. The NDA was filed because Abvvie’s two-part combo drug regimen — paritaprevir/ritonavir with ombitasvir — achieved an SVR12 of 95% in Chronic Hepatitis C patients with genotype 1b. These patients were treatment-naive, meaning that no previous treatment had been given to them. In addition these patients were non-cirrhotic, meaning that they were not in an advanced liver disease state. The trial the company ran was known as the GIFT-1 study which recruited 116 patients. Abbvie already has a three-part combo drug regimen approved in the U.S. by the FDA for Chronic Hepatitis C infection and is marketed as Viekira Pak. This additional approval would put Abbvie in a great spot in terms of global reach for its Hepatitis C treatment regimen.

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