This week has seen a fair share of FDA advisory committee and European Medicines Agency action this week. Let's see how these decisions are effecting the current stock prices of these companies
Savient Pharma (OTC:SVNT)
This morning, the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing author isation for the medicinal product Krystexxa, 8 mg/ml, concentrate for solution for infusion intended for the treatment ofsevere debilitating chronic tophaceous gout in adult patients who may also have erosive joint involvement and who have failed to normalize serum uric acid with xanthine oxidase inhibitors at the maximum medically appropriate dose or for whom these medicines are contraindicated. The applicant for this medicinal product is Savient Pharma Ireland Ltd. They may request a re-examination of any CHMP opinion, provided they notify the European Medicines Agency in writing of their intention within 15 days of receipt of the opinion.
This more positive news for Savient after recently replacing its CEO and CFO, signifying in my opinion the continued turn-around story for the company. Savient's stock traded as low as $0.48 on July 17th of this year as investors anticipated the company would be judged as being in default on its convertible notes. However, on July 23rd, The Delaware Court of Chancery decided that Tang Capital Partners LP and some of Savient's other debtholders didn't have the standing to take action to appoint a receiver for the New Jersey-based company and that Savient hasn't defaulted on its convertible notes.
Savient has made significant steps in getting its house in order, but 3rd quarter sales results will go a long way in telling us the ultimate fate of the company. In its Aug 8th conference call, and again at the Rodman & Renshaw presentation on September 10th, CEO Louis Ferrari guided that double digit sales growth is expected to continue. Earnings are set to be released October 29th.
Investors are receiving this news well, as Savient is currently trading at $2.29 $0.16 (7.51%) .
Ariad Pharma (NASDAQ:ARIA)
Ariad and its partner Merck (NYSE:MRK) expect to hear the EMA's CHMP decision today regarding the company's collaborative drug, Ridaforolimus. In June of this year, the FDA issued a complete response letter (CRL) regarding the New Drug Application (NDA) for ridaforolimus. Ridaforolimus is an investigational oral mTOR inhibitor under development for maintenance therapy for patients with metastatic soft tissue or bone sarcoma who have stable disease or better after four or more cycles of chemotherapy.
The CHMP is expected to follow suit with the FDA, and reject Ridaforolimis for marketing approval. Ridaforolimus is not the Ariad's "bread and butter" drug -- Ponatinib is. Ponatinib is an investigational BCR-ABL inhibitor that also selectively inhibits certain other tyrosine kinases in preclinical studies, including FLT3, RET, KIT, and the members of the FGFR and PDGFR families of kinases.
Ariad anticipates approval and commercial launch of ponatinib in the U.S. in the first quarter of 2013. Also, the Marketing Authorization Application (MAA) for ponatinib, submitted in August, has been validated by the EMA, commencing their review of the application. The CHMP has granted ARIAD's request for accelerated assessment of the MAA.
Ponatinib is expecting an FDA decision by November 26th after submitting an NDA to the agency in late July -- 60 days priority review.
Investors should keep their focus on Ponatinib, as approval, or lack thereof for this drug will make or break the company -- not Ridaforolimis.
Ariad is currently trading at $24.18 $0.14 (0.58%), so this is having a slight effect on its stock price.
Isis Pharma (ISIS)
The Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the FDA voted 9 to 6 late yesterday that Genzyme had provided sufficient efficacy and safety data to support the marketing of Kynamro. the FDA has set a target action date under the Prescription Drug User Fee Act (PDUFA) of January 29, 2013. An application for marketing approval of Kynamro is also pending in the European Union.
Isis is partnered with Genzyme, a Sanofi company (NYSE:SNY) for Kynamro. Kynamro (Mipomersen) is a cholesterol-reducing drug candidate. It is an antisense therapeutic that targets the messenger RNA for apolipoprotein B.It is administered as a weekly injection. However, Isis might be facing stiff competition from Aegerion Pharma's (NASDAQ:AEGR) Lomitapide, a similar drug to Kynamro, also received a positive recommendation from the EMDAC of the FDA this past Wednesday, with a more decisive vote of 13-2.
Lomitapide is a small molecule microsomal triglyceride transfer protein inhibitor, or MTP-I which is an oral, once-a-day treatment for patients with severe lipid disorders. Lomitapide is indicated for its ability to reduce low density lipoprotein (LDL-C) or bad cholesterol levels in patients with HoFH and reduce triglyceride (TG) levels in patients with a severe form of hypertriglyceridemia called FC. The mechanism of action of lomitapide is to reduce lipid levels in the blood by preventing the liver and intestines from secreting lipids into the blood stream. Lomitapide has been evaluated in over 900 patients in one Phase III study, eight Phase II studies and fourteen Phase I studies.
Aegerion's solution here might be the better drug as Kynamro has raised serious questions over safety concerns about an imbalance in neoplasms (tumors).
An FDA report released on Thursday cited "The incidence of reported neoplasms (benign and malignant) was 3.1% (23/749) in mipomersen treated patients versus 0.9% (2/221) in placebo-treated patients.
Isis is currently trading at $9.25 $0.37 (3.85%), while Aegerion is trading at $21.30 $0.36 (1.72%). We can see that investors/traders agree withe the assessment of both companies and their drugs.
Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.
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