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R&D: The Poignant Loneliness--Brief Case Studies of 8 New Listed DrugsBY: Dynah Luo | Category: Industry-News | Submitted: 2013-01-26 06:12:36
Article Summary: "Source: Creative Biomart : Before a research or practice being carried out, it was always given much aspiration and hope but some of them were gained with bitterness and loneliness eventually. These days, some of such post-development of top-level 'blockbusters' might repeat the same misery..."
1. Provenge (Sipuleucel-T)
Application: Prostate Cancer
The biggest problem of Provenge was that it missed the proper launch time. It was the first therapeutic drug that recognizes and kills prostate cancer cells by stimulating patient's immune system when Dendreon Corporation submitted file to the FDA and got approval, it really was a truly revolutionary new product. However, when it was forced to go back to do another study to prove the efficacy, its time-to-market is delayed until 2011 when the entire market has changed.
Dendreon priced Provenge for $ 93,000. Some physician wondered, "Does the drug worth so much by extending the originally limited survival time of patients (median 4.1 months)?" Through the bitter launch, the estimated $ 3.5 billion to 4 billion of annual sales of Dendreon was needed to be cut.
In Benlysta (a human monoclonal antibody that inhibits B-cell activating factor) sales, Human Genome Sciences (HGS) sunk into trouble soon. After three quarters of sales, the first market approval during 56 years used for lupus only made $ 59 million in sales, which was far away from the expected $ 2.5 billion.
One of the biggest problems of HGS was that it gave an impression of much "high price" for prescription doctors, as well as the Medicare reimbursement concern that troubled the Provenge listing. HGS's stock slid to a bargain basement price. However, this brought an opportunity to HGS's long-term partner -GlaxoSmithKline, which acquired HGS as the only bidder for $ 3 billion.
Application: Heart Disease
As early as in 2009, Sanofi treated Multaq (dronedarone) as one of its most important late-stage development products. The following year on July 2, it was approved by FDA when Morgan Stanley analysts believed, "Although the product has defects, â‚¬ 3 billion sales per year could be easily reached."
In order to get FDA approval, Sanofi had to add black box warning on its label, and described that NYHA (New York Heart Association cardiac functional classification) class IV heart failure patients, or â...¡ ~ â...¢ heart failure, loss of compensatory function who requires hospital treatment or referral to a specialized heart failure clinic patients shouldn't use this drug. FDA also reminded the medical staff that in very few conditions, the use of Multaq might cause serious liver damage.
Then the security risks of this drug has become more and more obvious, the drug regulatory authorities of many countries are deeply concerned about its side effect on liver, cardiovascular and lung diseases. The French thought the first line drug position of Multaq was not proper, thus they reduced its proportion of Medicare reimbursement. Its available range is also given new restrictions, for example, in US, FDA recommends that it cannot be prescribed to patients with permanent AF.
After the third attempt, Somaxon's Silenor (doxepin) finally got approved by the FDA in the spring of 2010. Experienced the long road of thorns, Somaxon's made great effort on this, it invested $ 170 million on Silenor. But the approval didn't let it found the right partner to launch the drug. Dependent on a weak marketing power, the company had to difficultly seek survival in such crowded market. In the third quarter of sales in 2011, its sales only reached $ 3.7 million.
The subsequent fate of Somaxon continued to deteriorate. The third quarter of last year, its sales declined to slightly over $2 million, which only can pay the "lunch" fee of the pharmaceutical company. The Somaxon found itself launched a new product at the wrong time and wrong place.
Application: Acute Coronary Syndrome
At the end of 2010, Brilinta was approved by the FDA and AstraZeneca had many expectations on it. The blood thinning agent was thought can be used when Bristol-Myers Squibb and Sanofi's clopidogrel standard treatment was invalid or cannot tolerate, compared to another direct competitor with long history than it - Lilly's Effient (prasugrel) also has some unique advantages. At that time, analysts estimated its sales could up to $ 2.7 billion by 2015.
However, FDA disrupted the plans and hopes of AstraZeneca in that FDA requested a new round of data analysis and sowed the seeds of doubt. The Brilinta was finally approved by the FDA in July 2011. AstraZeneca does have some clinical data that support the fact that Brilinta's effect on some patients is better than clopidogrel. But today clopidogrel's similar drugs had already been launched in the market, which is definitely tough for Brilinta to compete with the same price brand drug Plavix.
Application: Prevention of Preterm Delivery
In February 4, 2011, KV Pharmaceutical Company launched a long-acting natural progesterone to prevent preterm birth drug--Makena (hydroxyprogesterone caproate injection). The sale price was $ 1,500 per dose. However, many pharmacies have similar compounding of this drug for only 10 to $ 20 per dose.
In order to save the product, KV priced down to $ 595. Later KV failed to obtain bankruptcy protection, and then the original research company of Makena, Hologic, required recovering the license, which lost $ 45 million transfer fee for K-V. KV's poor management led to the "catastrophe" of this new drug.
Application: Colorectal Cancer
On August 2012, FDA granted the Zaltrap (aflibercept) as a second line therapy for colorectal cancer. Like many new anti-cancer drugs, the drug is expensive with monthly $ 9,600 cost. However, the expensive price of Zaltrap is not commensurate with its expected return.
Three physicians of Memorial Sloan - Kettering Cancer Center criticize Zaltrap in the New York Times, said, "Our Center has removed Zaltrap out of our drug list and we use another less expensive alternative medicine - angiogenesis inhibitor bevacizumab that has fairly equal efficacy." Regarding this, Sanofi initially defense the price of Zaltrap, but subsequently had to make a concession that agreed to give a 50% discount.
Application: Restless Leg Syndrom
For the collaboration agreement between GlaxoSmithKline and XenoPort on Horizant (gabapentin butyl) for the treatment of restless legs syndrome, the pharmaceutical giant GSK paid the upfront cost of $ 75 million and more than $50 million pay for a stage. However, the FDA used three years to approve this drug until it was confirmed that the tumors observed in animal won't pose threat to humans.
However, almost from the beginning of their commercialization efforts, their cooperation sunk into trouble. The first quarter of market sales was only $ 1.3 million, which led to the dispute of the two companies, XenoPort blamed GSK for breach of contract, and GlaxoSmithKline immediately made counterclaim.
Subsequently the two companies spent much energy in legal disputes, which in some way affected the market conditions of Horizant. Not long ago, the two companies agreed to go separate ways for each other.
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