Shire ($SHPGY): Acquires Pervasive Therapeutics Vascular Assets

Shire Pharma (NASDAQ:SHPGY) will acquire the vascular assets of Pervasis Therapeutics (Cambridge, Mass.) in a deal valued at up to $200 million, including an undisclosed upfront payment and milestones. The deal includes Vascugel, a biodegradable implant containing human endothelial cells in Phase II testing to prevent hemodialysis vascular access failure in patients with end-stage renal disease (ESRD). Shire said Vascugel will add to its regenerative medicine portfolio, which includes marketed diabetic foot ulcer therapy Dermagraft, gained last year through the acquisition of Advanced BioHealing. 

Shire will also gain Pervasis' PVS-10200, a formulation of tissue-engineered allogeneic endothelial cells in the Phase I/II TRIUMPH trial to prevent restenosis in peripheral arterial disease (PAD) patients undergoing angioplasty or a stent procedure. Pervasis will retain its non-vascular assets, which include preclinical programs in cancer, inflammation and orthopedics. The deal is expected to close this quarter.

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China Cord Blood (NYSE: CO)Gets a $65 million injection - $CO

China Cord Blood Corporation (“CCBC”) (NYSE: CO) and Kohlberg Kravis Roberts & Co. L.P. announced that they have entered into agreements under which KKR China Growth Fund L.P., a China focused investment fund managed by KKR, is expected to invest $65 million into CCBC, the largest cord blood banking operator in China, to support its further business expansion and to capitalize on China’s fast growing healthcare services industry.

Cord blood contains large quantities of stem cells that, if stored properly, can later be used to treat life-threatening diseases. The applications of cord blood stem cells continue to expand, and can now be used to treat over 80 types of diseases, such as leukemia, lymphoma, thalassemia and inherited immune system disorders. This progress in medical research and clinical applications continues to raise public awareness of the benefits of storing cord blood.

Listed on the New York Stock Exchange since 2009, CCBC was the first licensed cord blood banking operator in China, providing collection, testing, processing, and storage services. CCBC runs the largest cord blood banking network in China in terms of geographical coverage, with exclusive licenses to service the city of Beijing, Guangdong Province and Zhejiang Province. This area covers more than 180 million people and has 1.9 million new births annually.

Ting Zheng, Chairperson and CEO of CCBC stated, “CCBC provides an important service to families across China who want to safeguard the lives and health of their newborns. We are delighted to have KKR as our partner. Our senior management team is most impressed by KKR’s global franchise and its strong local track record in China. KKR’s investment is undoubtedly a strong vote of confidence in our company, our management team and our vision for the future.”

“CCBC runs an impressive operation that meets stringent quality standards and provides a critical medical service to its customers. As we continue to build our China portfolio, we are excited to support a company that is dedicated to improving healthcare services and making a positive impact on lives in China,” said David Liu, Member of KKR and CEO of KKR Greater China.

“CCBC has an effective platform and its services will increase in value as its application expands,” said Julian Wolhardt, Member of KKR. “In addition, CCBC has an outstanding and dedicated management team who has worked together for almost a decade. We are very delighted to partner with them to build CCBC into a market leader in its field.”

China Cord Blood Corporation is the first and largest umbilical cord blood banking operator in China in terms of geographical coverage and is the only cord blood banking operator with multiple licenses. Under current PRC government regulations, only one licensed cord blood banking operator is permitted to operate in each licensed region. China Cord Blood Corporation provides cord blood collection, laboratory testing, hematopoietic stem cell processing and stem cell storage services.

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BioSmart Brief: Highlights NeoStem's PreSERVE Trial $NBS

PreSERVE-AMI tests autologous stem cell treatment for heart attack
Doctors at Orlando Health have started a trial as part of the nationwide PreSERVE-AMI study of pelvic bone marrow stem cells in treating tissue damage after a heart attack. The study of autologous transplant will involve 160 patients at 34 sites. American City Business Journals/Orlando, Fla.

Pharma's iPad attraction marks tech adoption shift @ Fierce Biotech It

Historically, drug makers have been one of the most reluctant groups to seek out and implement new information technologies. As Ryan McBride explains at FierceBiotechIT, however, that is beginning to change.  He writes that "one prime example of this shift is the industry's well-documented affection for Apple's ($AAPL) iPad. Pharma companies are buying the tablets by the thousands, doling them out to sales reps and executives, some of whom probably already own the popular devices."

McBride points to Zackary King, senior vice president and general manager of Trinity Pharma Solutions, who says that 75% of his company's customers have adopted the iPad. King commented, 

"Their adoption of the iPad has been amazingly fast. And I think it's mostly driven by end-users. People like you and I bought iPads and iPhones years ago. When you work for a big company, you wonder why they can't enable your iPad or your iPhone. I think the demand actually came from the users, unlike in the past where technology decisions came from the IT department." 

King's Waltham, MA, company provides analytics and business intelligence software for commercial organizations in biopharma and medical devices. He thanks the iPad for helping to open pharma executives' eyes to web-based software like Trinity's:

 "I think, with the iPad, one of the amazing things that we are seeing is that it's driving the adoption of SaaS (software as a service). These tablets aren't really made for heavy local power applications, so most everything has to be delivered via the Internet."

Read more at FierceBioTechIT.com. 

Cytomedix Reports Publication of Positive Autologel Wound Healing Data in Ostomy Wound Management (CMXI)

Cytomedix, Inc. (OTCBB: CMXI) is a biotechnology company developing advanced tissue regeneration technologies. Our primary focus is on commercializing autologous cell based therapies that facilitate the body’s natural healing processes for enhanced healing and tissue repair.  Our commercial portfolio is based on autologous platelet rich plasma (“PRP”) platform technology, and includes the Angel® Whole Blood Separation System (“Angel®”) and the AutoloGelTM System (“AutoloGel”). 

The Company has announced the publication of positive clinical data regarding its AutoloGel™ System in the April 2012 issue of Ostomy Wound Management in an article entitled, "A Retrospective, Longitudinal Study to Evaluate Healing Lower Extremity Wounds in Patients with Diabetes Mellitus and Ischemia Using Standard Protocols of Care and Platelet-Rich Plasma Gel in a Japanese Wound Care Program." 

According to the press release,

"The purpose of this retrospective study was to capture evidence-based treatment outcomes in limb salvage patients with complex ulcerations treated in Japanese wound care centers using AutoloGel platelet-rich-plasma gel (“PRP”). The study involved 40 wounds in 39 severely compromised patients with comorbidities of diabetes mellitus (DM), lower limb arteriosclerosis, ischemia and infection. The majority of the patient population (34 or 85%) had DM and 24 of those also had arteriosclerosis. Diabetic foot wounds were Wagner Grade lll (77%) (deep ulcers with cellulitis or abscess formation, often with osteomyelitis) and lV (23%) (localized gangrene). Skin perfusion pressures of less than 40 mm Hg were recorded in 25 or 63% of the patients, and less than 30 mm Hg in 20 or 50% of the patients indicating critical limb ischemia which can impair healing. The study included a run-in period of 75.3 days on average, during which revascularization and/or debridement along with standard-ofcare therapy with advanced modalities were administered."

The Key Findings of the study are as follows:

• During the run-in period, no wounds healed and wound measurements for area, depth and volume actually increased
• Following AutoloGel treatment, 32 or 83% of wounds healed in an average of 145.2 days (p=0.00002) using an average of 6.1 treatments
• Mean changes over time in area (p=5.0x10-7), depth (p=1.2x10-6), and volume (p=7.3x10-5) were all statistically significant

Dr. Chugo Rinoie, DPM, ABPO, CWS, Chief of Podiatric Surgery, Wound Healing Center, Methodist Hospital of Southern California, Arcadia, CA, Medical Director, Millennia Wound Management, Inc, Los Angeles, CA, as well as a corresponding author of the publication, noted,

"These data demonstrate that autologous PRP gel can be used to heal long-standing, chronic Wagner III and IV wounds in patients with diabetes and moderate-to-severe peripheral arterial disease whose skin perfusion pressure indicates poor healing prognosis and probable limb amputation. Further, the associated wound care database now comprises over 200 wounds from Japanese AutoloGel patients."

Martin P. Rosendale, Chief Executive Officer of Cytomedix, commented, 

“We are delighted to have this compelling data published in a peer-reviewed journal as this study demonstrates that patients with chronic diabetic wounds and compromised arterial flow can heal and avoid limb amputation with AutoloGel treatment. These data support and validate previous studies showing that AutoloGel significantly and reliably improves the rate of complete healing, speed and progress to healing, and quality of life as compared with standard wound care. The complexity and comorbidities associated with these wounds would have excluded them from any randomized controlled trial making this real world comparison study even more compelling. We believe data such as these strongly support our case for a positive National Coverage Determination from the Centers for Medicare & Medicaid Services to cover autologous PRP gel for the benefit of the various stakeholders interested in improving clinical wound care outcomes while lowering overall costs.”

Dr. Rinoie will be presenting these positive data in a poster presentation at the upcoming Symposium on Advanced Wound Care-Spring 2012 being held in Atlanta, Georgia from April 19-22, 2012.

 Read more at Cytomedix.com. 

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NeoStem Announces the Addition of Jonathan Sackner-Bernstein, MD, Past FDA Official, as Vice President, Clinical Development and Regulatory Affairs (NBS)

NeoStem, Inc. (AMEX: NBS; Stock Twits: $NBS) is engaged in the development and manufacturing of cell-based therapies in the U.S.  Its January 2011 acquisition of Progenitor Cell Therapy, LLC ("PCT") is central to the Company's strategic mission of capturing the paradigm shift to cell therapy.

 The Company announced the addition of Jonathan Sackner-Bernstein, MD, FACC to Neostem as the Vice President of Clinical Development and Regulatory Affairs.

He brings to the Company over 20 years of experience as a clinical cardiologist and medical researcher with leadership in healthcare management. Dr. Sackner-Bernstein will join the team to advance Amorcyte's PreSERVE AMI Phase 2 trial in addition to providing regulatory support for NeoStem's product pipeline.

 

NeoStem's Chief Medical Officer Dr. Andrew Pecora commented, 

"Jonathan's experience at the FDA and with Clinilabs, coupled with his experience as a cardiologist, make him a perfect choice to develop Amorcyte's AMR-001, in part by leveraging his relationships with clinical investigators and leaders in the cardiology community. In terms of our Amorcyte product under development, a CD34+ cell for the preservation of heart muscle function after a large AMI, we continue to see data in the competitive landscape that supports our notion that this is the right strategy for success. As we are accruing our Phase 2 trial we are noting the incidence of low ejection fraction after a ST segment elevation myocardial infarction. Even with advances in the standard of care that have reduced the adverse events associated with an AMI, a meaningful percentage of patients are being found to have a left ventricular ejection fraction of less than 45 percent several days after an AMI. This is the group at risk for adverse events that AMR-001 is being tested on to determine if it will preserve heart muscle function to prevent adverse events."

Dr. Sackner-Bernstein's past experience includes servings as the Associate Center Director for Technology and Innovation at U.S. Food and Drug Administration's Center for Devices and Radiological Health from 2008 to 2011, and serving as Chief Medical Officer at the clinical research organization, Clinilabs, where he established a Phase 1 research unit from 2006 to 2008. From 1993 to 2003, he was an assistant professor of medicine at the Columbia University College of Physicians and Surgeons.

His academic accomplishments include "contributions to medical therapy of heart failure and patients following heart attack as well as leadership in changing the paradigms of drug development in heart failure. Dr. Sackner-Bernstein also founded ExVivos, LLC, a privately-held company focusing on engineering tissues and organs from human cells for the development of drugs, vaccines and biological products. Dr. Sackner-Bernstein earned his B.S.E. from the Moore School of Electrical Engineering at the University of Pennsylvania and his M.D. from Jefferson Medical College. He completed training in Internal Medicine and Cardiology at Mount Sinai Hospital in New York. In addition, he holds Secret Clearance from the U.S. government."

Dr. Robin L. Smith, Chairman and CEO of NeoStem, stated,

"Jonathan's clinical experience as a cardiologist, and work at the FDA and Clinilabs, make him a perfect addition to the NeoStem senior management as we focus our resources to execute on our operational business plan which includes developing our most mature asset, AMR-001, enrolling patients in the Amorcyte Phase 2 trial and building our contract manufacturing business, Progenitor Cell Therapy (PCT). NeoStem has successfully repositioned the company through the acquisitions of both PCT and Amorcyte, effectively transforming our company to one that is focused on the development of novel cell based therapeutics and, as such, management is focused on execution to build investor confidence and bring value to our shareholders."

 Read more at Neostem.com. 

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BIO.org Supports Obama's JOBS Act - Fair or Foul?

Last week the JOBS Act was passed by President Obama with rare bipartisan support. The Jumpstart Our Business Startups Act aims to ease restrictions on access to investment capital for “Emerging Growth Companies” (EGCs). EGCs are defined as companies that have completed its Initial Public Offering after December 8, 2011, that has less than $1 billion in total revenue. EGCs will be exempt from certain reporting and filing procedures with the Securities and Exchange Commission, be allowed to engage in more aggressive funding solicitation efforts and be able to take advantage of new “crowdfunding” opportunities via Internet investors.

The JOBS Act’s stated purpose is to increase job creation and economic growth by improving access to public capital markets for emerging growth companies. The JOBS  Act relaxes the disclosure requirements for certain companies going public, provides alternative ways for private companies to raise capital and allows some companies to stay private longer. Like everything in Washington these days it has been controversial ranging from cries of Wall Street scams to pro by Small Business here.

Most importantly for our market segment, the Biotechnology Industry Organization (BIO.org) supports the legislation here in their article:

"The JOBS Act: Critical Support for Today’s Emerging Biotech Company"

BIO.org is the world’s largest biotechnology organization. BIO is a 503c non-profit organization headquartered in Washington, D.C. They provide advocacy, business development, and communications services for more than 1,100 members worldwide. Members are involved in the research and development of innovative healthcare, agricultural, industrial and environmentalbiotechnology products. Corporate members range from entrepreneurial companies developing a first product to Fortune 500 multinationals.

At Seeking Alpha, Ampio Pharmaceuticals Follows Multiple Pipeline Strategies With Potential; $CTSO

CytoSorbents Corporation (OTCBB: CTSO) is a critical-care focused therapeutic device company using blood purification to treat life-threatening illnesses. These are common, major conditions seen in the intensive care unit (ICU), such as sepsis and infection, severe trauma, burns, lung injury, and pancreatitis, that afflicts millions of people each year yet lacks effective therapies, leading to a mortality rate that often exceeds 30%. Failure of multiple organs, such as the lungs, heart, kidneys and liver, is the leading causes of death from these conditions, for which very little can be done today. Hospital acquired infections are another leading cause of death in the ICU. CytoSorbents is developing novel and advanced blood purification therapies designed to actively prevent, mitigate, or reverse the development of organ failure and infection, thereby potentially reducing illness severity and helping patients to heal and recover faster. 

On Seeking Alpha, VFC's Stock House wrote an article discussing the reasons a company might choose to seek drug approval overseas before pursing the US market. In the case of Ampio Pharmaceuticals (AMPE), for example, "the reason why Ampio is not seeking a US approval for Zertane in the treatment of PE is quite simple - the FDA does not recognize the condition as a medical need." He noted that "Cytosorbents Inc. (CTSO) is another company that keyed in on Europe before setting sights on the US market."

He explained,

"There is little doubt that when it comes to making money in the pharmaceutical and health care industries, the US market is the place to be. Companies know that and investors thrive on making money based on that fact. That said, contrary to the belief of some, there is a whole wide world out there other than the United States, and in many cases it is cheaper to do business and conduct trials overseas than it is back home...

The more cautious investor may shy away from investing in a company that looks to see if a product works overseas first before then concentrating on the FDA in an effort to save a few dollars, but others may be attracted to a business model that might not leave a company as exposed to the loan shark financing deals that are prevalent in the US to keep the early stages of the pipeline going."

Read the full article at Seeking Alpha.