Gilead Sciences Announces First Quarter 2012 Financial Results ($GILD)

Gilead Sciences, Inc. (Nasdaq: GILD) is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and experimental drug candidate,  they seek to improve the care of patients suffering from life-threatening diseases around the world. Gilead's therapeutic areas of focus include HIV/AIDS, hepatitis, serious respiratory, cardiovascular, and metabolic conditions, cancer and inflammation. Their portfolio of 14 marketed products includes a number of category firsts, including the only complete treatment regimens for HIV infection available in a once-daily single pill – Atripla® (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg), approved in 2006, and Complera® (emtricitabine/rilpivirine/tenofovir disoproxil fumarate), approved in 2011.

Gilead Sciences has announced their first quarter financial results for 2012.  Total revenues for the first quarter of 2012 increased 19 percent to $2.28 billion,  with a net income of $442.0 million.  The increased revenue is attributed to product sales driven by Gilead's antiviral franchise, including sales of Atripla^(R), Truvada^(R), and the launch of Complera^(R)/Eviplera^(R) in 2011.

Read the full press release here.

Market watchers have commented on this announcement and the success of The Company's antiviral sales. Brean Murray Carret & Co. commented,

"Gilead’s HIV franchise had a strong quarter, with newly launched Complera

contributing to the strength of core products Atripla and Truvada. However, investor

focus remains on the Hepatitis C opportunity and the development plans for GS‐7977.

We continue to believe Gilead represents a compelling investment opportunity and

see the strong quarter as a reaffirmation of the value of the company’s current suite of

commercial products. We believe further upside will be derived from the approval and

commercialization of GS‐7977 for Hepatitis C next year.  Gilead’s HIV franchise had a strong quarter, with newly launched Compleracontributing to the strength of core products Atripla and Truvada. However, investorfocus remains on the Hepatitis C opportunity and the development plans for GS‐7977.We continue to believe Gilead represents a compelling investment opportunity andsee the strong quarter as a reaffirmation of the value of the company’s current suite ofcommercial products. We believe further upside will be derived from the approval andcommercialization of GS‐7977 for Hepatitis C next year."

Read the Brean Murray full report here.  

Vertex Reports First Quarter 2012 Financial Results and Provides Update on Launch of KALYDECO™ ($VRTX)

Vertex (Nasdaq: VRTX) creates new possibilities in medicine. Their team discovers, develops and commercializes innovative therapies so people with serious diseases can lead better lives. Vertex scientists and collaborators are working on new medicines to advance the treatment of hepatitis C, cystic fibrosis, epilepsy and other life-threatening diseases. Vertex isn’t a conventional pharmaceutical company. Each and every person at Vertex is driven by a passion for fearless innovation and a bold desire to transform the lives of millions with new medicines. Vertex has ongoing worldwide research programs and sites in the U.S., U.K. and Canada and employs over 1800 people.

Vertex has announced their first quarter financial results for 2012.  The Company released that it earned revenues of approximately $439 million, including net product revenues of approximately $357 million from INCIVEK^® (telaprevir) and approximately $18 million from KALYDECO^TM (ivacaftor).  KALYDECO^TM and INCIVEK^®, The Company reports continued investment which will allow them to continue multiple clinical studies including Phase 2b studies of all-oral, short-duration treatment regimens for hepatitis C and JAK3 inhibitor VX-509 for rheumatoid arthritis, as well of KALYDECO in people with types of cystic fibrosis. 

Jeffrey Leiden, M.D., Ph.D., President and Chief Executive Officer of Vertex commented,  

"Since January, approximately 600 people with cystic fibrosis have started treatment with KALYDECO in the U.S., underscoring the importance of this new medicine to the CF community and further demonstrating our ability to develop and launch transformative new medicines. With INCIVEK, we continue to treat thousands of people with hepatitis C, and we are highly encouraged by the early success seen with this medicine outside the U.S., where our collaborator Janssen has attained a market-leading position in Europe and availability of INCIVO in more than 15 countries around the world."

The full press release can be viewed here.  

Market watchers have also commented about these results.  Brean Murray Carret & Co. stated, 

"Vertex launched Kalydeco in 1Q12 and in a little more than two months captured a

large portion of G551D patients.    This is a strong indication that the closely knit CF

community was anxious for a new treatment option and reinforces the potential for a

blockbuster market opportunity if Vertex can expand beyond the G551D patient

population.   Incivek sales were disappointing coming in below our expectations. We

continue to see declining Incivek sales as a drag on the stock despite the positive early

signals from the company’s CF franchise.  Vertex launched Kalydeco in 1Q12 and in a little more than two months captured alarge portion of G551D patients.    This is a strong indication that the closely knit CFcommunity was anxious for a new treatment option and reinforces the potential for ablockbuster market opportunity if Vertex can expand beyond the G551D patientpopulation.   Incivek sales were disappointing coming in below our expectations. Wecontinue to see declining Incivek sales as a drag on the stock despite the positive earlysignals from the company’s CF franchise."

 

Read the Brean Murray full report here.  

Athersys ($ATHX) holds meeting with FDA to discuss MultiStem

Athersys announced that a scheduled meeting with the FDA was held to discuss the results of its recently completed clinical trial involving the administration of MultiStem to patients being treated for leukemia or other conditions that place them at risk of Graft versus Host Disease (GvHD).

• Additionally, the company discussed with the FDA its proposed plans for the next phase of clinical development, answered questions and obtained feedback on a number of specific issues related to the potential study parameters and proposed trial design.
• The company intends to provide further information about its plans as it finalizes development of a detailed trial and statistical plan and receives additional FDA feedback.

AtheroNova Signs Agreement for Development of Clinical Trial Supplies ($AHRO)

AtheroNova (OTCBB: AHRO) is an early stage biotech company focused on discovery, research, development and licensing of novel compounds to reduce or regress atherosclerotic plaque deposits.  The Company's focus on compounds to reduce or eliminate atherosclerotic plaque deposits addresses the most lucrative segments of the multi-billion dollar prescription drug market: cardiovascular disease and stroke prevention.

AtheroNova announced it has signed an agreement with Frontage Laboratories, Inc. to commence analysis of their AHRO-001 compound and formulate a production plan in preparation for Phase I trials.  Frontage Laboratories, Inc., a leading pharmaceutical contract research organization, was chosen based on previous successful relationships with The Company. Work formulating and validating manufacturing procedures of manufacturing AHRO-001 tablets will begin immediately.

AtheroNova CEO Thomas W. Gardner commented,

"Frontage has been extremely diligent in dealing with the technical and physical requirements of our AHRO-001 compound and we look forward to commencing our project in the coming days.  We are very confident that Frontage will deliver a quality product in a timely manner. We continue to adhere to our vigorous development path and anticipate additional exciting development milestones in the coming months."

View the full press release here.  

Soligenix Announces Further Progress with ThermoVax™ for Long-Term Vaccine ThermoStability ($SNGX)

Soligenix, Inc. (OTCBB: SNGX) is a development stage biopharmaceutical company committed to developing products to treat life-threatening side effects of cancer treatments and serious gastrointestional diseases, and vaccines for certain bioterrorism agents.  Soligenix has two areas of focus: 1) a therapeutics segment dedicated to the development of products for orphan diseases and areas of unmet medical need such as pediatric Crohn’s disease, acute radiation enteritis, and Graft-versus-Host disease (GVHD), and 2) a vaccine/biodefense segment to develop vaccines and therapeutics for military and civilian applications.

Soligenix announced further progress in the development of ThermoVax™.  ThermoVax™is a vaccine thermostabilization technology that could prove effective in keeping vaccines viable during extreme temperatures.  Prototype vaccines kept at elevated temperatures for more than three months have demonstrated stability and effectiveness after exposure to environmental stress conditions.

Robert N. Brey, PhD, Chief Scientific Officer of Soligenix, commented,

"We continue to be pleased with the data generated thus far with ThermoVax™.  The ability of vaccines to withstand extreme temperatures is a significant step forward in vaccine technology. ThermoVax™ may also enable preparation of otherwise difficult multivalent (protective against multiple pathogens) formulations. We plan to apply ThermoVax™ to other conventional vaccines that require refrigeration."

Read the full article here.  

MD Becker Partners 3rd Annual "Cancer Immunotherapy: A Long-Awaited Reality" Conference

On Thursday, October 4, 2012, MD Becker Partners will host its Third Annual "Cancer Immunotherapy: A Long-Awaited Reality" Conference at the New York Academy of Medicine in New York City.  This unique, single-day conference event unites founding visionary researchers, clinicians, business leaders, key investors, and other stakeholders to engage in discussions, exchange information, highlight opportunities, and showcase leading companies in the field of cancer immunotherapy.  
 
To view the keynote address and select plenary sessions and panel discussions from last year's event, please visit the firm's new YouTube page at: www.youtube.com/mdbeckerpartners
 
A direct link to last year's keynote address by Axel Hoos, M.D., Ph.D., Co-Chairman of the Cancer Immunotherapy Consortium, is displayed below:

MD Becker Partners is a boutique management and strategy consulting firm focusing on both public and private companies in the life science industry. We also work with venture capitalists, institutional investors, and others that provide capital to these companies. As a strategic advisor and partner, we provide a full range of services to help our clients increase visibility, unlock stakeholder value and access resources to grow their business. To accomplish this, we integrate relations, strategy, and operational capabilities and apply them to carefully conceived and expertly enacted tactics. Visit our website to learn more at www.mdbpartners.com.

Human Genome ($HGSI) RBC says current GSK bid for Human Genome undervalues sum of parts over long-run ($14.64)

• The firm sees $15-23 fair value but notes that a CVR might make sense for GSK if no compromise can be made. RBC believes GSK could raise its bid at least once but assumes that HGSI wants the higher end of RBC's valuation range. However, the firm notes there is no guarantee GSK will raise its bid and they don't see any other serious bidders that would bid materially higher.
• Rating is sector perform for HGSI. Target raised to $15 from $10.
• Analyst is Michael J. Yee

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Soligenix ($SNGX): Announces further progress with ThermoVax

Soligenix announced that progress has been based on additional characterization of the stability of prototype vaccines that have been kept at elevated temperatures in excess of three months.

• Prior results have indicated that the company's aluminum-adjuvanted ricin toxin vaccine, known as RiVax, retained effectiveness and potency while stored at 40 degrees Celsius for one month when combined with the ThermoVax technology.
• Confirmatory results have now extended these initial observations to more than three months when the vaccine is kept at 40 degrees Celsius. In contrast, liquid RiVax vaccine when stored at 40 degrees Celsius rapidly degraded and no longer maintained its effectiveness.

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