Partnering Returned Assets can Rescue, Maximize Value

REUTERS/Brian Snyder

Deal terminations can throw even the most confident companies for a loop, dealing a blow to the perceived value of even still-promising assets. Finding a new partner saves the day, but it takes careful strategic planning, according to panelists at the recent Allicense 2014 meeting in San Francisco.

With more than 1,300 therapeutics deals announced in the last three years, according to Thomson Reuters Cortellis and Recap, some are bound to fall apart. The reasons behind break-ups can vary. Clinical partnerships are typically terminated by the partnering company as a result of non-compelling clinical data, lower than expected commercial opportunity, development delays or a reassessment of strategic fit, according to Locust Walk Partners LLC managing director and co-founder, Jay Mohr. (more…)

Share on LinkedInTweet about this on TwitterShare on Google+Share on FacebookShare on RedditDigg thisEmail this to someone

The ‘Danger Theory’ of Immune Recognition: 60 Years on from ‘Self Non-Self’

The ‘Danger Theory’ of Immune Recognition

Inducing tissue damage and inflammation to eliminate disease is a long established clinical concept. Historically, Hippocrates is claimed to have said, “Give me the power to induce fever, and I cure all diseases.” At the turn of the last century, William B Coley, a surgeon at Memorial Sloan Kettering Hospital, New York (from 1892 to 1936) used a mixed bacterial vaccine (Coley’s toxin) in a systemic way to treat patients with metastatic cancer. (more…)

Share on LinkedInTweet about this on TwitterShare on Google+Share on FacebookShare on RedditDigg thisEmail this to someone

Application of Personalized Medicine in CLL

REUTERS/Andres Stapff

CLL is the most common leukemia in the Western world, accounting for a third of all leukemia cases and an incidence of 4.2 cases per 100,000 individuals. Although observed in all age groups, the incidence of CLL increases from less than 1 per 100,000 in individuals aged 40 to 44 years to 30 per 100,000 aged 80 years and older, with the majority of people diagnosed with CLL being over 60 years of age and an average age of diagnosis of 72 years. Other risk factors for the disease include a family history of blood and bone marrow cancers and exposure to certain herbicides and insecticides. Patients with CLL may experience a wide range of symptoms, including pain and swelling of the lymph nodes, tiredness, fever and infection, and weight loss. Often symptoms are not experienced for several years and CLL is frequently detected following a blood test performed for other reasons. Between 25 and 50 percent of patients are asymptomatic when diagnosed. (more…)

Share on LinkedInTweet about this on TwitterShare on Google+Share on FacebookShare on RedditDigg thisEmail this to someone

Deal Making Still Continues its Torrid Pace, Report Finds

REUTERS/Tarek Mostafa

Deal making is continuing its breakneck pace in the life sciences sector with a combined total of almost $50 billion generated from 587 transactions in the first quarter of the year, according to data released in April by Thomson Reuters Recap at the Allicense 2014 meeting.

Similar to 2013, overall deals, which in addition to those involving biopharmas also includes medical devices, diagnostics and tools firms, continue to target early stage assets, leading creative deal making in which contingent-value agreements and option deals carry the day, said Laura Vitez, principal business analyst for Thomson Reuters Recap. (more…)

Share on LinkedInTweet about this on TwitterShare on Google+Share on FacebookShare on RedditDigg thisEmail this to someone

3-D Printing Breaks Through Confines of Traditional Med-tech Manufacturing

3-D Printing in Med-tech

Imagine a world in which people in need of an organ transplant could jump the wait list and have a new lung or kidney 3-D printed in a matter of days. It might sound like a science fiction plot, but 3-D printing has already saved lives and the world has only seen the tip of this technological iceberg. For the next two weeks, I will explore the potential of this seemingly futuristic technology, the challenges it presents, and where 3-D printing is likely to have the greatest impact in healthcare. (more…)

Share on LinkedInTweet about this on TwitterShare on Google+Share on FacebookShare on RedditDigg thisEmail this to someone

Follow the Label: New Keys for Alzheimer’s Disease

REUTERS/David W Cerny

Medical advances, an abundance of food and an increase in the general standard of living in Western nations is leading to an aging population. Road traffic accidents and natural disaster aside, the average life expectancy continues to rise. Of course, with greater longevity, there is a concomitant rise in the risk of a person succumbing to what might be referred to as geriatric diseases, including late-onset Alzheimer’s disease. (more…)

Share on LinkedInTweet about this on TwitterShare on Google+Share on FacebookShare on RedditDigg thisEmail this to someone

20th Annual EGA Meeting: Sustainability of the Generics Industry & European Health System

EGA Meeting

The 20th annual conference of the European Generic Medicines Association (EGA Meeting) focused on the sustainability of the European generics industry and the interdependence between an affordable healthcare system and a healthy generics sector. The generic pharmaceutical industry is continually meeting high regulatory costs and standards, while trying to increase greater access to products and medicines. The industry and EGA have a strong commitment to a healthier society, looking to put forward solutions for a sustainable healthcare system by working together with regulatory agencies. During the conference attendees had a chance to hear about the developments in the European generics market and learn about the major challenges the industry is currently facing. The event brought together approximately 200 stakeholders representing multiple countries and provided numerous opportunities to network with attendees. (more…)

Share on LinkedInTweet about this on TwitterShare on Google+Share on FacebookShare on RedditDigg thisEmail this to someone

Accelerated Approval Unlikely for AstraZeneca’s Ovarian Cancer Drug

1586_66_preview

The results of a recent vote by the FDA’s Oncologic Drugs Advisory Committee (ODAC) elicited audible groans from the audience in the agency’s Great Room. By a 9 to 2 tally, committee members had denied support for a request by AstraZeneca for accelerated approval of olaparib, an investigational drug proposed as maintenance therapy for specific cases of relapsed ovarian cancer. (more…)

Share on LinkedInTweet about this on TwitterShare on Google+Share on FacebookShare on RedditDigg thisEmail this to someone

MannKind’s Inhaled Insulin Afrezza wins FDA Approval

Inhaled Insulin Afrezza

June 2014 saw the first US approval of an ultra-rapid-acting inhaled mealtime insulin for diabetes, as MannKind’s Afrezza won FDA approval after a five-year regulatory struggle. The drug’s target market is a massive one with a severe medical need – there are 347 million diabetics worldwide, and the condition is predicted to be the seventh leading cause of death in 2030. However, inhaled insulins have not fared well in the past, although Afrezza has the potential to buck this trend. (more…)

Share on LinkedInTweet about this on TwitterShare on Google+Share on FacebookShare on RedditDigg thisEmail this to someone

Brazil: Opportunities and Challenges in Latin America’s Largest Pharmaceutical Market

REUTERSSergio Moraes

Latin America continues to be an area of rising investment for the pharmaceutical industry, with Brazil and Mexico leading the way. Not only is Latin America an attractive target for potential market entrants, with the help of regulatory changes and burgeoning partnerships, it solidifies its commitment to further expanding its presence on the global pharmaceutical marketplace. Keeping pace with this expansion is increasing oversight from the Brazilian regulatory authority for domestic and foreign market entrants alike. (more…)

Share on LinkedInTweet about this on TwitterShare on Google+Share on FacebookShare on RedditDigg thisEmail this to someone