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Earlier this week Roche Holding AG announced that it would pay $230 million to acquire the San Diego, CA-based biopharmaceutical company Anadys. The reason for the acquisition is to bolster Roche’s standing in the hepatitis C market which is projected to grow to as much as $15 billion annually by 2019.

Anadys has a fairly large experimental pipeline of hepatitis C drugs, the most advanced candidate being setrobuivr that is being clinically tested in combination with the generic antiviral drug ribavirin and Pegasys (PEGylated α-interferon) as a hepatitis C treatment.

The Anadys deal comes on the heels of an agreement last week between Roche and Merck & Co to jointly market hepatitis C treatments in the US. Merck recently won approval last May for Victrelis (boceprevir) the first new hepatitis C treatment in over a decade. Also, late last month Vertex Pharmaceuticals received approval for a new hepatitis C drug called Incivek (telaprevir). Anadys is also conducting early clinical trials on ANA773 as a possible treatment for hepatitis C infection, cancer and other chronic diseases.

In other news, GlaxoSmithKline (GSK) is rumored to be contemplating purchasing Maryland-based Human Genome Sciences (HGS), which recently received US approval for Benlysta a novel monoclonal antibody treatment for the autoimmune disease systemic lupus erythematous. 

Benlysta was the first new drug to be approved to treat lupus in over 50 years. GSK is HGS’s commercialization partner for Benlysta which is expected to be a blockbuster drug. The reason for the takeover rumors is likely HGS’s stock price which has fallen from 52-week high of $30 to its current value of $15 per share. 

Until next time...

Good Luck and Good Job Hunting!!!!!!!

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Shire, an Irish speciality pharma and rare diseases drug maker, today announced that it would purchase Connecticut-based Advanced BioHealing (AB) for $750 million in an all cash deal. 

The main reason for the deal was AB’s Dermograft, a regenerative bio-engineered skin substitute used for the treatment of diabetic foot ulcers (DFU). Dermagraft currently has roughly a 5 percent share of the potential $3 billion slow-healing DFU market, approximately $146 million in US sales last year, and Shire says the potential for growth in the DFU market is considerable. Also, AB had finished enrolling patients into multinational trials to investigate Dermagraft for the treatment of venous leg ulcers. If all goes as planned, a regulatory filling in the USA for the new indication is planned for the first quarter of 2012.

Shire tendered its offer to purchase Advanced BioHealing one day before the company was to launch an initial public offering of 13.4 million shares priced from $14 to $16. The IPO would have raised over $200 million and the company would have been valued at around $630 million. The deal was a strategic move for Shire that wants to expand its product offerings in the speciality pharma sector. It isn’t clear whether the acquisition will result in layoffs at AB. Unfortunately, all cash transaction typically do not bode well for the company this is being acquired.

In other news, Takeda, after denying reports earlier in the week that it intended to purchase Nycomed for $12.0 billion is expected to announce the deal today.

Until next time...

Good Luck and Good Job Hunting!!!!!!

Addendum: At the press conference this afternoon, Takeda tersely stated that it had not agree to purchase Switzerland's Nycomed. Stay tuned for the next installment of the saga!

Addendum to the Addendum: Takeda Pharmaceuticals and Nycomed  jointly announced today that Takeda has reached an agreement with the shareholders of Nycomed in which Takeda will acquire the Zurich-headquartered company for $13.6 billion ( 9.6 billion Euro) on a cash-free, debt-free basis. The boards of directors of each company unanimously approved the transaction which is expected to be completed within 90 to 120 days, making it a wholly owned subsidiary of Takeda, subject to antitrust clearance. The purchase would exclude Nycomed's U.S. dermatology business.

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The era of blockbuster drugs was officially declared over several years ago by many pharmaceutical analysts and pundits. Nevertheless, as the old adage goes “it’s difficult to treat old dogs’ new tricks!” After all, the blockbuster drug model has been the major driver of pharmaceutical and biotechnology markets for close to 50 years. Consequently, big pharma and biotech companies haven’t truly abandoned the possibility of finding potential new blockbusters. And, it appears that the blockbuster heir apparent may be drugs to treat rare aka orphan disease indications. 

At first blush, this strategy may not make a lot of sense. This is because rare diseases afflict only small numbers of patients (at least in the US and other Western nations). However, what may be considered a rare disease in Europe or the US may actually be less rare in countries with large populations like China and India. Further, while current rare diseases patient populations may be small, the cost of the drugs developed to treat them is extremely high. In some instances, the annual cost per patient can exceed several hundred thousand dollars. If you do the math, it becomes apparent that developing rare disease treatments or so-called niche busters can actually be very big business. 

The rare diseases business model has been perfected by Genzyme and many big pharma companies are trying to emulate it. To that end, big pharma’s push into rare diseases continues to gather momentum. So far this year Sanofi-Aventis has made an $18.5bn move for Genzyme, while Pfizer and GlaxoSmithKline have both created rare disease business units.

According to Glaxo’s estimates, 7,000 rare diseases have been identified and collectively this affects 6-8% of the world’s population; in the US and Europe alone rare diseases affect 25 million people. In addition mortality rates are very high, often at a very young age, and less than 10% of these diseases are treated with approved drugs.

To date, over 7,000 rare diseases have been identified. Companies involved in the new rare diseases treatment race have whittled the list down to roughly 200-250 disorders that represent a clear path for clinical, regulatory and commercial success. The criteria used to select these indications include identifying rare disorders with: 1) a relatively high prevalence rate, 20 an early age of onset, 3) a large unmet medical need and 3) a known molecular target. The indications have been broadly classified into four distinct groups:  metabolic disorders, autoimmune/inflammation, central nervous system and blood disorders.

While Genzyme identified, developed and commercialized its rare diseases treatments, it is likely that big pharma companies like Pfizer, Glaxo, and Merck will either in-license potential new treatments or acquire companies with platform technologies or drugs in various stages of clinical development. For example, Merck’s acquisition of Glycofi several years ago has allowed the company to enter into the rare diseases and biosimilar markets.

One of the major problems with extant rare diseases treatment is their excessive and oppressive costs. One can only hope that the increased competition in the rare diseases space will help to lower drug prices and make them more affordable for patients who suffer from these devastating and life-threatening disorders.

For more insights in to the orphan drug disease market, check out an article that I wrote for Life Science Leader this month

Until next time...

Good Luck and Good Job Hunting!!!!!

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After months of melodrama and acrimonious exchanges between Jim Cornelius and Carl Icahn, Eli Lilly, not Bristol-Myers Squibb, will acquire ImClone and gain access to the multibillion Erbitux franchise. In the end, Carl Icahn, ImClone’s Chairman, got the $70 per share that he wanted for ImClone stock.

BMS’s reluctance to purchase ImClone at the $70 per share price is puzzling. The Pharmalot blog reported that Jim Cornelius, BMS’s CEO, released the following statement after the ImClone/Lilly deal was finalized “We are pleased to have initiated a process that has resulted in the substantial increase of ImClone’s value for all of its stockholders. Perhaps Bristol-Myers has made a comfortable bid for ImClone which would be, in our view, very attractive to the company. If however, it did not succeed then it can liquidate its stake at a premium.” This makes about as much sense as Sarah Palin’s explanation of the factors responsible for global warming—the amount of money that BMS would garner if it liquidates its 16% stake in ImClone would pale in comparison to revenues that would annually accrue from Erbitux sales. Apparently I am not alone in my thinking. According to a financial analyst “the stake’s value independent of full ownership of IMCL is NOT strategic, and gets BMY nothing,”

In my opinion, Jim Cornelius’s failure to acquire ImClone (at any cost) has jeopardized BMS’s future. He had the opportunity to right the wrongheaded licensing deal that his predecessor Peter Dolan entered into with ImClone. The inability of BMS to retain at least partial ownership of its flagship biotechnology product doesn’t bode well for a company that is trying to reinvent itself as a “next generation biopharma company”—if there is a next generation at BMS.

 Until next time…

Good Luck and Good Job Hunting!!!!!!!

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Monoclonal antibodies (MAbs) directed against vascular endothelial growth factor (VEGF) receptors on cancer cells, have been found to slow the growth of a variety of cancers including colorectal, breast and lung.  While a number of blockbuster biotechnology products( based on these MAbs (Avastin by Genentech/Roche and Eribitux by Bristol-Myers Squibb/ImClone/Merck KGA) have been approved to treat a variety of different cancers their effectiveness as cancer treatments has been the subject of intense debate since their approvals.

Although numerous human clinical trials have shown that VEGF inhibitors slow the growth and development of tumors, they, as a class, don’t seem to significantly increase the survival time for most cancer patients. Further, Avastin and Erbitux are generally not used as stand alone treatments but are used in combination with more tradition anti-cancer chemotherapies. The high costs of these drugs, (Avastin’s worldwide sales hit $ 3.5 billion last year) and their variable effectiveness have caused many to question the usefulness of this class of drugs to treat cancer patients.

The well-publicized use of these drugs as cancer treatments coupled with anecdotal evidence about their effectiveness has put practicing oncologists between a rock and a hard place when it comes to treating patietns with cancer. In an article in Sunday’s New York Times one prominent oncologist said that depsite the controversy,  “I still use Avastin routinely. It’s not a slam dunk and, in fact, the incremental benefit may be more modest than we want to admit.” Others are more sanguine about VEGF inhibitors as cancer treatments “Even when these drugs ‘work,’ what kind of impact are you talking about?” said Fran Visco, president of the National Breast Cancer Coalition. But we market them and give them to everybody.”  

Nevertheless, most oncologists find it difficult to withhold Avastin or Erbitux from cancer patients seeking hope. As one oncologist put it “ When I am not sitting in front of a patient, I think about whether drugs like Avastin are worth it to society. But when facing a seriously ill patient, who, based on clinical trial results, might benefit — even if only a little — from Avastin, I think about the patient’s needs.” 

Regardless of their therapeutic value, the main issue with this class of anti-cancer drugs is cost. Avastin treatment costs patients about $4000-$9000 per month— Eribitux treatment is even more costly! While Medicare and most private insurers cover 80% of the cost, patients can be responsible for 20% or more of treatmetn costs.  As posited in the Times article “If Avastin were inexpensive or if it cured cancer or even held it at bay, as the drug Gleevec does for blood cancer, few might care.”

Are anti-VEGF drugs real cancer treatments or expensive red herrings? Clearly, the jury is still out on that one. That said, I think that only cancer patients can truly provide an accurate response to that question!

Until next time…

Good Luck and Good Job Hunting!!!!!!!

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