Sanofi appears ready to move past the discussion stage and lay its cards out on the table in a formally presented letter which spells out its terms. The pharma company will be doing its best to avoid paying more than the upper 70s, and is already hinting at a hostile takeover attempt, even before it’s made a formal offer for the company. Still, other analysts scoff at the notion that Genzyme should go for less than $80 a share ($21.3 billion).

“$80 was the valuation in 2008, before the manufacturing issues, and without those issues it would be trading there now,” Orbimed Advisors’ Sven Borho tells Bloomberg. “This hasn’t been a great year and you can’t base a valuation on it. The growth rate in 2011 could easily be 20 percent or more, and that’s one of the highest growth rates in biotech.”

Important will be Carl Icahn’s role. Already well in the black after paying as much as $58.24 for a chunk of Genzyme stock, just about everyone expects Icahn will use his new-found powers inside the big biotech to push hard for the highest price Genzyme can get. One of the big questions, though, is whether anyone, Icahn included, could get a bidding war started. Reuters notes that most of the other big players have either got their own extravaganzas to complete or have sworn off such deals. Even J&J could find Genzyme too big to swallow if the asking price goes over $20 billion.

Source: FierceBiotech

The study covers several points that can boost medical innovation such as the importance of public-private collaborations; government support for research, technology transfer and IP protection; a modernized regulatory policy and approval process; and capital investment.

These points are important challenges for medical innovation. However, I consider differences between biotechnology SMEs and large pharmaceutical companies as a challenge for medical innovation as well. Specifically the lacking ability of big pharma companies to develop radical innovative technologies. Strategic management is very important for medical innovation. My research concerns the ability of explorative innovation of large pharmaceutical companies. Where these large companies are currently looking at biotechnology SMEs for innovative technologies, one might think why pharmaceutical companies are not exploring internal innovation capabilities. If they’d develop such capabilities they might also be more efficient in retaining technologies or projects acquired from biotechnology SMEs. This is the basic philosophy behind my research and I hope to find ways for big pharma to increase their capabilities of explorative innovation.

The large company from Switzerland  has obtained a worldwide co-exclusive licence for the biomarker PI3K (phosphoinositide 3-kinase) from Qiagen to develop diagnostic assays.

The PI3K pathway is mutated in more cancer patients than any other, Roche noted, playing “a significant role in colorectal, gastric, breast and endometrial tumours, among others”. Drugs that inhibit PI3K are “a significant focus of current cancer drug development”, the company added, stating that its Genentech unit has several molecules at the early stage “targeting various points along this pathway”.

Paul Brown, chief executive at Roche Molecular Diagnostics, said there is “abundant clinical evidence that the PI3K biomarker will play a significant role in the future of oncology treatment”. He added that diagnostic assays that detect mutations in PI3K “will be an essential component of cancer drug development and personalised healthcare”.

The USA’s Johns Hopkins University owns the patent for the PI3K biomarker and had previously granted an exclusive licence to Qiagen’s wholly owned subsidiary DxS, now known as Qiagen Manchester.

Source: PharmaTimes

Sanofi will pay $75 million as an upfront-payment to TargeGen, which is developing small molecule kinase inhibitors for the treatment of certain forms of leukaemia, lymphoma and other haematological malignancies and blood disorders.

Further milestone payments, principally based on the development of the San Diego-based firm’s lead product TG 101348, could take the value of the deal up to $560 million.

The purchase gives Sanofi an experimental treatment for myelofibrosis, a bone marrow disorder that disrupts the body’s production of blood cells, causing fatigue and an enlargement of the spleen. TG 101348 is a potent inhibitor of Janus kinase-2, an oral agent being developed for the treatment of patients with myeloproliferative diseases including myelofibrosis. The compound has completed a Phase I/II trial in patients with MF and additional studies are planned to start in the second half of 2010.

Besides MF, Sanofi says that TG 101348 could be effective in a variety of other haematological malignancies, such as polycythemia vera, a blood disorder in which the bone marrow produces too many red blood cells. Currently, there are no approved or adequately effective therapies to treat these diseases called myeloproliferative neoplasms that affect around 400,000 patients in the USA and Europe.

“The acquisition of TargeGen represents a further significant step to increase our engagement in the field of hematological malignancies,” Marc Cluzel, Sanofi’s executive vice president of R&D, said in the statement.

Source: Bloomberg Businessweek

The 2010 Pharmaceutical R&D Factbook, compiled by CMR International and released on Monday, painted a gloomy picture of the global pharmaceuticals sector.

New drugs launched within the last five years accounted for less than 7 percent of industry sales in 2009, down from 8 percent in 2008, the Factbook showed, highlighting the big problems that companies are having in trying to reinvigorate their portfolios.

Many companies – including Pfizer Inc, GlaxoSmithKline Plc and AstraZeneca Plc - have been taking a knife to research operations in a bid to improve returns, a trend which analysts expect to gather momentum this year and next. As a result total research and development (R&D) expenditure dropped by 0.3 percent in 2009, after a 6.6 percent rise in 2008 and rapid growth seen in earlier years.

A total of 26 new molecular entities (NMEs) were launched onto the global market in 2009, an increase on 2008′s 20-year low of 21. But the number of launches last year was still only a little more than half the peak level in 1997.

“The latest data shows that poor productivity in 2009 continued to be exacerpated by the low success rate for drugs in late stage development and a decline in sales from new drugs launched within the last five years,” said Hans Poulsen, head of consulting at CMR International.

“The increase in NME launches compared with 2008 offers some positive news. However, with data indicating a continued drop in overall success rates, it remains to be seen if the industry can reverse a 10-year trend in declining R&D output.”

CMR said the number of experimental drug projects terminated at the final Phase III stage of development had doubled in the period 2007-2009 compared with 2004-2006.

Source: Reuters.com

Big Pharma needs innovations, brand new technologies and new ways of preventing and treating diseases. Their out-dated technologies and products will not help them remaining profitable. The only question is: Is buying small biotech companies with their innovations enough to remain profitable?

Inovio, announced today that the peer-reviewed journal Molecular Therapy has published a paper entitled “IL-28B/IFN-lambda3 Drives Granzyme B Loading and Significantly Increases CTL Killing Activity in Macaques.”

With this study, they have shown that they are able, with their innovative DNA vaccine technology-platform, to increase immune responses to diseases in non-human primates.

The paper, co-authored by researchers from Inovio and collaborators from University of Pennsylvania School of Medicine, notes that co-delivery of Inovio’s immunoadjuvant, a DNA plasmid encoding interleukin (IL)-28B, with an Inovio optimized SynCon(TM) DNA vaccine using its proprietary electroporation (EP) technology significantly enhanced antigen-specific killer T cell responses in rhesus monkeys.

A gene immunoadjuvant is a DNA plasmid encoded with the genetic blueprint of an important, naturally occurring immune molecule such as IL-28B. When this DNA plasmid is co-delivered with a DNA vaccine, both the vaccine and, in this case, IL-28B proteins are produced by the same cell. The presence of an immunoadjuvant such as IL-28B may enhance the attraction of particularly important immune cells such as dendritic cells or killer T cells. Generation of CD8+ killer T cells are considered instrumental in clearing cancerous or infected cells from the body and imperative to achieving sufficient potency of new vaccines against cancers and chronic infectious diseases such as HIV and hepatitis C.

The study results, recently published in Molecular Therapy, compared Inovio’s platform with Merck’s adenovirus serotype 5 (Ad5) vaccine, considered to be the most immunogenic among viral vectors. Inovio has also reported from its phase I clinical study of a SynCon(TM) DNA vaccine against HPV/cervical cancer the achievement of T cell response levels thought sufficient to provide therapeutic benefit.

Let’s hope they are right and that their technological applications also show therapeutic benefits in phase II and phase III trials. This might bring us a step closer towards preventing and treating cancer and other life-threatening diseases.

Sources: Inovio Pharmaceutical, Inc.; Yahoo Finance

This technology can function as a state-of-the-art biomarker for monitoring and diagnosis of Alzheimer’s Disease. In addition, it will also make the regions of the brain much easier to target with plaque disrupting drugs.

This year Avid has successfully completed their study and the full data will be presented at an  international meeting of the Alzheimer’s Association in Honolulu on July 11. However, it must still be approved by the FDA. But if they hold up, it’ll mean that for the first time ever physicians will have a reliable method for diagnosis of Alzheimer’s Disease.

Let’s hope it really works!

Source: New York Times

With this blog I am establishing my first endeavors as an internet-entrepreneur. Here, I’d like to share with you interesting things about developments in the biotechnology and pharmaceutical industry.

I am very interested in this sector because very interesting discoveries and innovations are made here, things that can significantly improve the quality of life for many many people struggling with medical needs that are not yet met.

I sincerely hope you will enjoy my website and please feel free to leave comments and let me and others know what you think about the items I post.

Have a great one! Much love and respect.

Kenneth