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BIO SmartBrief

Daily Dose Newsletter

Daily Dose Newsroom is a Daily Dose of Wall Street research and news in the Healthcare, Biotech, and Biomedical sectors.

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Friday
Mar092012

Aastrom ($ASTM) Raises Capital - $40 MLN Private Placement

Aastrom Biosciences (ASTM) completed a $40M private placement with Eastern Capital ($1.81 -$0.01) Net proceeds to Aastrom, after placement fees and other offering expenses, are ~$38M.

The company intends to use the net proceeds from the financing for general corporate purposes, including research and development expenses related to the pivotal Phase 3 REVIVE-CLI clinical trial with ixmyelocel-T initiated in February 2012.

At closing, Aastrom issued approximately 12,300 shares of Series B convertible preferred stock to Eastern Capital at a price of $3,250 per share.

The shares will accrue dividends at a rate of 11.5% per annum during the 5-year term.

The Series B preferred stock is convertible into shares of the company's common stock only after 8-Mar-17 at a rate of 1,000 common shares for one preferred share.

There were no warrants issued in connection with the financing and Eastern Capital will not take a board seat.

Daily Dose Conclusion: This strikes us as a last resort financing. Aastrom has the capital to see the CLI trial to its conclusion, and if the trial hits, they can pay off this "expensive financing" and if it does'nt its essentially the end of Aastom. As such we view this deal as raising risk for investors and making the "B" in Binary now a capital letter.

Friday
Mar092012

Dendrion ($DNDN): J&J unblinds Zytiga trial in chemo-naive CRPC

Johnson & Johnson (NYSE:JNJ) unblinded the Phase III COU-AA-302 trial in chemotherapy-naive castration-resistant prostate cancer after Zytiga plus prednisone showed "evidence of clinical benefit" on the co-primary endpoints of radiographic progression-free survival (PFS) and overall survival (OS) vs. prednisone alone. J&J based the decision on the recommendation of an independent DMC, which conducted an interim analysis. Details of the analysis were not disclosed. The trial enrolled 1,088 chemotherapy-naive patients with asymptomatic or mildly asymptomatic metastatic CRPC.

Zytiga is approved in the U.S. in combination with prednisone to treat patients with metastatic CRPC who have received prior chemotherapy containing docetaxel. Next half, J&J plans to submit an sNDA to FDA, as well as worldwide regulatory applications, for Zytiga to treat men with metastatic CRPC who have not yet received chemotherapy. J&J gained Zytiga through its 2009 acquisition of Cougar Biotechnology Inc., which received rights to the product from BTG in 2004. BTG was up 15.30 to 365p on Thursday. Zytiga is an inhibitor of steroidal enzyme 17 alpha-hydroxylase/C17, 20 lyase (CYP17).

Zytiga would be a potential competitor to Provenge sipuleucel-T, which is marketed by Dendreon Corp. (NASDAQ:DNDN) for asymptomatic or minimally symptomatic metastatic CRPC. Dendreon fell as much as 17% on Thursday before closing off 7%, or $0.76, to $10.11. Provenge consists of autologous dendritic cells loaded with a fusion protein of prostatic acid phosphatase and an immunostimulatory cytokine

Friday
Mar092012

Athersys Announces Private Placement Financing - $ATHX

Athersys, Inc. (Nasdaq:ATHX), a leader in the emerging field of regenerative medicine, today announced that it has entered into definitive agreements with certain accredited investors in connection with a private placement financing transaction. Upon the closing of the transaction, Athersys will receive gross proceeds of approximately $9.0 million in exchange for the issuance of approximately 4,347,827 shares of Athersys common stock and warrants to purchase approximately 4,347,827 shares of Athersys common stock. The warrants will be exercisable for a period of five years at an exercise price of $2.07 per share. Athersys intends to use the net proceeds of the transaction to support its ongoing business development and clinical efforts, and for general corporate purposes.

Piper Jaffray & Co. acted as sole lead placement agent for the offering, William Blair & Company and First Analysis Securities Corporation acted as co-placement agents and WBB Securities, LLC acted as financial advisor.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.

Full press release

Thursday
Mar082012

Discovery Labs ($DSCO): Fourth time's a charm !

Discovery Laboratories (DSCO) gains on Surfaxin approval : Discovery Laboratories Inc. (NASDAQ: DSCO) gained as much as 44% yesterday (Wednesday) before closing up 9%, or $0.33, to $4.08 after FDA approved Surfaxin lucinactant late Tuesday to prevent respiratory distress syndrome in premature infants. Discovery plans to launch the humanized lung surfactant in the U.S. late this year. We can't recall if this is the fourth or fifth time that Surfaxin went up for approval but Kudos to the DSCO team for hanging in there to get it done.

Conclusion: Discovery (DSCO) is worth watching now. While this is a niche product, there is a real market opportunity in prematurely born infants and we believe with the great need that specialty and big pharma has DSCO could be acquired at a premium, so we would be inclined to own shares and see what happens.

Thursday
Mar082012

Dendreon ($DNDN) : Gets whacked based on a competitors Good News

Dendreon is off from its recent high when sales guidance looked a bit soft and the stock is down again today, this time on news in the competitive landscape of prostate cancer that competitive product, JNJ's Zytiga data must be strong.

As one analyst wrote in their institutional blog, "What Happened ?  JNJ had news out that the Phase 3 trial for Zytiga in patients treated (prior to chemotherapy) was unblinded based on the unanimous recommendation of the independent data monitoring committee (IDMC). This is an unusually positive move for an IDMC to make !

This decision was driven from results of the planned interim analysis of the data which included the primary endpoints Overall Survival and Progression Free Survival.  The IMDC went one additional step to recommend that patients in the control (placebo arm) be treated with Zytiga.

So the data must be great for the trial to be stopped early. This means that the market opportunity for Provenge just got smaller.  Why ? Provenge is going after a similar marketplace, pre-chemo exposed prostate cancer men that are asymptomatic.  So clearly Zytigia cuts into the Provenge patient population pool.

Daily Dose Conclusion: Given the two recent negatives that hive hit Dendreon we back away from our positive bias and would step back and see where DNDN stabilizes before jumping into the story.

Wednesday
Mar072012

Ventrus Biosciences releases VEN-309 Trial Webcast for patients with Hemorrhoids $VTUS

Ventrus Biosciences (NASDAQ: VTUS) is a development stage specialty pharmaceutical company focused on the development of late-stage prescription drugs for gastrointestinal disorders, specifically hemorrhoids, anal fissures and fecal incontinence. There are approximately 12.5 million Americans suffering from hemorrhoids, 7 million from fecal incontinence and over 4 million from anal fissures. The company's product candidate portfolio consists of three late-stage drugs - VEN307 for hypertension and angina, VEN308 for fecal incontinence, and VEN309 for symptomatic hemorrhoids - intended to treat these conditions, for which, to our knowledge, there are no currently FDA-approved prescription drugs in the US.

Ventrus announced that it is now enrolling patients in its VEN309 study, an important phase III clinical trial. The primary objective of the VEN309-Hem-SE3-001 study "is to evaluate the effect of a 5HT2a antagonist ointment (iferanserin) on cessation of bleeding, pain, and itching when administered intra-anally twice daily (BID) for 14 days in subjects with symptomatic internal hemorrhoids."

Key eligibility requirements* for participating in the study include:

  • Males or non-pregnant females, ages 18 to 75 years.
  • Symptomatic internal hemorrhoids, Grades I-III.
  • Bleeding (with itching and/or pain) from hemorrhoids for two consecutive days prior to randomization.
  • Complete colon evaluation within three years; no malignancy within five years.

*A full list of patient eligibility criteria is available upon request.

More information available at the VEN309 trial website. Additionally, Dr. Steven D Wexner, Chairman of the Department of Colorectal Surgery at Cleveland Clinic Florida, was featured in a webcast providing additional information about hemorrhoids and the background of the study:

Wednesday
Mar072012

An in-depth look at electronics counterfeiting; $APDN

Applied DNA Sciences Inc. (OTCBB: APDN; Twitter: $APDN) sells patented DNA security solutions to protect products, brands and intellectual property from counterfeiting and diversion. SigNature DNA is a botanical mark used to authenticate products in a unique manner that essentially cannot be copied, and provide a forensic chain of evidence that can be used to prosecute perpetrators. Applied DNA Sciences (APDN) is the only company in the world that is making use of the complex codes embedded in botanical DNA as the ultimate solution to counterfeiting.

Between the National Defense Authorization Act for 2012, Amendment 2012 requiring the Pentagon to enact more aggressive procedures and strategies for counterfeit detection, and Applied DNA Sciences' research partnership with University at Albany's College of Nanoscale Science and Engineering (CNSE), counterfeiting has been a hot topic in the news recently.  One company recently suspended as a defense contractor after a years-long investigation into its selling of counterfeit parts, Hong Dark Electronic Trade Company, provides a vivid glimpse into the counterfeiting industry as well as the specific risks the Department of Defense faces with the influx of fake parts. 

A memorandum from the Department of the Air Force revealed the vast impact that this single company had on the Department of Defense:

"Approximately 84,000 suspect counterfeit electronic parts purchased from Hong Dark entered the DoD supply chain, and many of these parts have been installed on DoD aircraft, including C-17, C-130J, C-27J, P-8A Poseidon, AH-64, SH-60B, and CH-46."

Additionally, a background memo submitted to a November, 2011 hearing before the Senate Armed Services Committee  contained the following description of the counterfeiting process:

"Much of the raw material of counterfeit electronic parts is salvaged electronic waste (e-waste) shipped from the U.S. and the rest of the world to Hong Kong. From Hong Kong, waste is trucked to cities in mainland China, such as the counterfeiting district of Shantou in Guangdong Province, where electronic parts may be burned off of old circuit boards, washed in the river, and dried on city sidewalks. Once washed and sorted, parts may be sanded down to remove the existing part number, date code (which tells you when a part was made), and other identifying marks. In a process known as “black topping,” the tops of the parts may be recoated to hide those sanding marks. State of the art printing equipment may then be used to put false markings on the parts. When the process is complete the parts can look brand new."

Legitimate microchip manufacturers operate highly controlled environments, investing billions of dollars "in state-of-the-art facilities and take extreme precautions to prevent particles of dust, moisture, or other elements from damaging their products." Comparing this process to the one "used by counterfeiters, where chips may be burned off boards, washed in dirty rivers, dried on the ground, and remarked with newer or different part numbers," it is easy to see the risk that these parts pose. 

Unfortunately, the defense industry is particularly vulnerable to the flood of counterfeit parts. The director of the DOD’s Microelectronics Activity Unit explained, "The defense community is critically reliant on a technology that obsoletes itself every 18 months, is made in unsecure locations and over which we have absolutely no market share influence." The nature of the risk combined with the defense industry's particular vulnerability to counterfeit parts helps explain the push for increased accountability at all steps in the defense industry supply chain. 

 

Thursday
Mar012012

JMP Securities company report on Aastrom Biosciences ($ASTM)

Aastrom Biosciences, Inc.
ASTM - $1.79, $69M market cap
Jason N. Butler, PhD; +1 212 906-3505; jbutler@jmpsecurities.com

Solid progress as CLI Phase III trial gets underway; reiterate Market Outperform rating and $6 price target. Aastrom announced that it has initiated the Phase III REVIVE trial, evaluating the company's autologous cell therapy, ixmyelocel-T for the treatment of patients with critical limb ischemia (CLI). The timing of this news is in line with our expectations and we anticipate that enrollment could be completed with approximately 18 months, with data read out in 2H14. We continue to believe that the SPA-backed Phase III trial has a higher than average probability of success based on the impressive results from the randomized Phase IIb RESTORE CLI trial as well as the design and powering assumptions for Phase III. Additionally, we anticipate the emergence of further value-driving catalysts in 2012 as we gain more visibility on advancing ixmyelocel-T in broader CLI patient populations and indications (e.g. dilated cardiomyopathy), currently not included in our valuation. Our $6 price target is derived by applying a 5x multiple to our projection for ixmyelocel-T sales of $571MM in 2018, discounted by 35% per year.