Vivus: A Bet on Well-Funded, Late-Stage Pipeline Print E-mail
Tuesday, 03 March 2009 06:56
Vivus Inc. (VVUS) is a small-cap specialty pharma stock included in the ETF Innovators Preventive Medicine Index which is one of a trio of companies developing late-stage prescription weight loss drugs. Orexigen Therapeutics (OREX) will report additional Phase 3 results for Contrave around mid-year and hopes to file a NDA by year-end. Arena Pharma (ARNA) is expected to report Phase 3 results for lorcaserin by the end of this month. Vivus expects to post Phase 3 results around mid-year for Qnexa with a NDA filing planned before year-end. Nearly two-thirds or 65% of U.S. population is classified as obese or overweight with a three-fold increase in adolescent obesity rates over the past three decades. Obesity is the second leading cause of preventable deaths behind smoking and weight loss is proven to decrease mortality while also improving blood sugar control in diabetics. Over one-third (35%) of people in the U.S. have a lifetime of developing Type 2 diabetes and the trend is clearly increasing as a result of obesity rates, especially in the younger population.
Global Stem Cell and Regenerative Medicine Index Print E-mail
Wednesday, 04 February 2009 04:18
The ETF Innovators Global Stem Cell and Regenerative Medicine Index includes 40 companies with market caps less than $1B at the index inception and the total market value of the index will be tracked as a gauge of investor and trader sentiment toward stem cell companies from a starting value of 3,928 on 2/22/09 and current value of 3,860 as of 2/25/09 - down 1.7% from the closing value last week.
Caraco Pharma Awaits FDA Inspection in May Print E-mail
Wednesday, 04 February 2009 04:11
I spoke with the investor relations representative for Caraco Pharma (CPD) earlier this week and received some clarity on the expected timeline for resolving the major overhang on the stock price related to the FDA warning letter over Form 483 concerns by the agency stemming from quality control issues raised during an inspection of manufacturing facilities last year.   Caraco has responded in full to the warning letter and the FDA will evaluate the corrective actions taken by the Company at its next scheduled inspection, which is expected to occur some time in May. Caraco believes it is compliant with the FDA's cGMP regulations related to manufacturing and quality control and the issue remains the top focus at the Company, reflected by investments in personnel and facility upgrades.   The Company expects the FDA inspection in May to be the final step in resolving the warning letter issues as the agency will evaluate Caraco's upgrades in manufacturing and quality control at the Detroit facility to determine if these actions satisfy the agency's Form 483 concerns.
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