AP Pharma appoints oncology specialist as senior VP

by JoelLane 19. October 2012 15:55

Robert Rosen, AP Pharma Specialty pharmaceutical company AP Pharma has appointed the former global head of oncology at Bayer Healthcare as its senior VP and Chief Commercial Officer.

Robert Rosen will lead the launch of APF530, AP Pharma’s drug to prevent chemotherapy-induced nausea and vomiting.

He will become a director of the company once the drug has successfully establishes a market presence.

John Whelan, President and CEO of AP Pharma, said: “Robert’s deep and extensive experience commercialising oncology drugs will be instrumental as we enter the commercialisation phase of the company.”

AP Pharma specialises in developing injectable drugs using its Biochronomer polymer-based drug delivery platform, which can reduce the frequency of injection from daily to weekly or fortnightly.

APF30, the company’s lead product, is used to prevent both acute-onset and delayed-onset nausea and vomiting caused by chemotherapy.

Rosen led Bayer’s cancer drugs operation from 2005 to 2011 – including the launch of Nexavar (sorafenib) for the treatment of renal cancers.

Before that, he was VP of oncology at Sanofi-Synthèlabo, where he was responsible for launching the colon cancer drug Eloxatin (oxaliplatin).

European MS market needs new solutions

by JoelLane 13. March 2012 14:18

Pf clinical news The European market for multiple sclerosis (MS) treatments is suffering from a lack of innovative treatment options and wider disease awareness, a new report says.

According to growth analysts Frost & Sullivan, more patient-friendly therapeutic systems – such as oral rather than injectable drugs – would improve clinical outcomes in this difficult area.

Sub-optimal diagnosis and treatment reinforce the perception that MS is ‘untreatable’, resulting in poor patient compliance, the report notes.

F&S estimate the European MS drug market – immunosuppressants, immunomodulators and corticosteroids – at $3.2 billion in 2010, due to reach $5.38 billion in 2017.

A chronic and often fatal neurodegenerative disease, MS affects nearly 550,000 people in the EU.

According to F&S Research Analyst Deepika Pramod Chopda, “The rising number of people suffering from MS is resulting in higher demand for therapeutics. This, coupled with strong pipeline development, is pushing robust growth in the overall market.”

However, he noted, poor disease awareness and patient compliance are limiting progress in this therapy area. “Refined drug delivery technologies, mode of drug delivery (oral or injectable), and several other factors will encourage the use of MS drugs among patients,” he said.

“Novel treatment options will also promote the concept of combination therapies, accelerating market development.”

In addition, Deepika said, the lack of sensitive diagnostics is limiting the application of drug therapies.

“Non-compliance with MS treatment procedures remains a major challenge,” he argued. “Establishing end-user confidence has become difficult due to unsatisfactory therapeutic results.”

The solution, he said, lies in public education through healthcare forums and organisations of the more innovative treatment options, combined with measures to make such options more widely available.

Counterfeit Avastin provokes call for stronger laws

by JoelLane 29. February 2012 12:30

Pf industry news The discovery of fake vials of cancer drug Avastin in the US has prompted a call by The Lancet for stronger international laws against counterfeiting.

The counterfeit vials of the Roche drug, distributed in the US medical system, contained various laboratory chemicals but no pharmaceuticals.

The case has revealed a complex supply chain involving wholesalers in the UK, Denmark and Switzerland, with a possible source in Egypt or Turkey.

According to the International Journal of Clinical Practice, such global supply chains have resulted in worldwide sales of counterfeit medications doubling between 2005 and 2010 to $75bn.

The Lancet has called for “a binding, international standard for criminalising the manufacture and distribution” of counterfeit drugs to be launched by the WHO and backed up with stronger regulatory oversight and control.

The MHRA, which is participating in the investigation, commented that the counterfeit vials had “incorrect expiry dates and fake batch numbers”.

The manufacture of the fake Avastin was not sophisticated: several organic chemicals were included, but no active pharmaceutical ingredients.

The opportunity for concealment lay in the existing global supply chain. MHRA has stated that the vials were supplied to the US market via a UK wholesaler, buying from a Danish wholesaler, buying from a Swiss wholesaler.

Beyond that, it has been claimed, there may have been an Egyptian supplier and possibly a Turkish source of the vials.

The case reflects the growing risk of counterfeiting to high-cost injectable drugs as well as to oral medications.

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