Beyond the Bio Run-Up strategy of selecting a basket of small/micro-cap stocks with pending binary events such as FDA decisions and clinical trial results, another means of achieving diversification is by selecting a basket of companies with different types of pending catalysts. Below are some examples of how to categorize pending bio-catalyst events and some specific examples for each category.
1.) Long-Term Hold: Amarin Corp. (NASDAQ:AMRN) ($2.37, $234 million market cap)
AMR101 (Ethyl-EPA) is a prescription-grade omega-3 fatty acid that has been marketed in Japan for over 10 years as EPADEL by Mochida Pharma. Ethyl-EPA is differentiated from Glaxo's (NYSE:GSK) $1 billion dollar product LOVAZA (omega-3-acid ethyl esters) in the following key areas:
- no fishy smell / taste
- lacks Ethyl-DHA omega-3 fatty acid component, which can raise bad cholesterol (LDL) levels
- potential to address a much larger patient population including those with triglyceride levels of 200-500 mg/dL vs. LOVAZA, which is indicated for patients with triglyceride levels greater than 500 mg/dL
Amarin is fully funded through a potential NDA filing (projected to occur in 2012) with ongoing partnership discussions and the Company expects to report top-line results from both pivotal studies (the MARINE and ANCHOR clinical trials are being conducted under a Special Protocol Assessment or SPA agreement with the FDA). Amarin is focused on the US market (where Glaxo derives over two-thirds of its LOVAZA sales) and the next catalysts for the Company include completing patient enrollment in the pivotal studies and a potential partnership for the US market.
2.) Under the Radar Foreign ADR: ChemGenex Pharma (OTC: CXSPY.PK) ($4.13, $78 million market cap)
ChemGenex received a Complete Response Letter (CRL) from the FDA in April, following a March meeting of the Oncology Drug Advisory Committee (ODAC) for OMAPRO (omacetaxine mepesuccinate), seeking approval for treatment of chronic myeloid leukemia (CML) patients that have a specific (T315I) mutation and have failed standard treatment with GLEEVEC (imatinib).
The CRL did not contain a request for a new clinical study and no request was made to enroll additional patients in the Company's pivotal study.
The Company is working to validate a companion diagnostic test for the mutation and to correlate positive OMAPRO treatment outcomes in this group, which typifies the trend toward personalized medicine - especially in the field of oncology where a better understanding of cancer at the molecular level has led to niche treatment options rather than a single treatment option for the disease.
ChemGenex has partnered OMAPRO with Hospira (NYSE:HSP) in Europe, Mid-East, and parts of Africa for an upfront payment of A$17.8 million and the potential for an additional A$119.4 million in development / sales milestones while retaining rights in all other regions, including North America. At the end of 1Q10, ChemGenex had A$14.9 million in cash and the Marketing Authorization Application (MAA) review for European marketing clearance is ongoing after being validated for review in November 2009.
3.) Get Paid to Wait: AstraZeneca (NYSE:AZN) ($45.02, $65 billion market cap, 7.6% dividend yield)
AZN is awaiting a FDA Advisory Panel review for its investigational oral anti-platelet treatment (blood thinner to reduce incidence of clots) BRILINTA (ticagrelor) on 7/28/10, seeking approval for the reduction of major adverse cardiac events in patients with acute coronary syndrome (ACS). A final FDA decision on the NDA is expected during late 3Q10.
On 6/2/10, the Antiviral Drugs FDA Advisory Committee voted 14-3 that motavizumab (being developed as follow-on product to SYNAGIS) should not be licensed for marketing to prevent serious respiratory syncytial virus (RSV) disease in high-risk infants with a final FDA decision expected by the end of 2Q10.
www.mikehavRx.com is your prescription for stock index investing updates focused on the healthcare sector, medical innovation, and pending binary events such as FDA decisions and clinical trials. The actively managed HavRx Regulatory Catalyst Index update report is currently tracking 584 entries and 381 companies (including approximately 200 stocks trading under $5 per share and 36 private companies). Promo codes (50% discount) are available for college students, investment clubs, and subscribers to my previous FDA Calendar or similar services.
Disclosure: Long AMRN, CXSPY
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