¿Cuál será en sí el efecto de este precedente jurídico en el mercado farmacéutico mexicano? México es un mercado emergente y el área con mayor crecimiento hasta la fecha es la de biocomparables. A pesar de que actualmente, sólo existen alrededor de cinco empresas que se dedican de lleno al desarrollo de biocomparables en México, el acceso a este mercado ha incrementado y seguramente crecerá rápidamente en los próximos años. El desarrollo de medicamentos biocomparables requiere el uso de células vivas, así que la imposibilidad de patentar moléculas de origen humano cambiará el ambiente regulatorio en México, afectando desde investigadores que descubren la molécula hasta autoridades regulatorias y por supuesto a pacientes. Hasta la fecha, la Comisión Federal para la Protección contra Riesgos Sanitaros, COFEPRIS, ha actualizado y agilizado los trámites para otorgar bioequivalencia a medicamentos biotecnológicos y biocomparables, mostrando así su disposición para el crecimiento de estas industrias en el país. Aunque aún existen muchas posibilidades de mejora en este aspecto, hemos visto que las autoridades mexicanas han mostrado mucha más aceptación en el desarrollo de terapias con células madre autólogas, tema que es muy debatido en países como Estados Unidos.

Frente a un mercado global de constantes cambios donde las regulaciones parecen multiplicarse y volverse más estrictas, ¿Cuál será la reacción de las autoridades regulatorias respecto al desarrollo de moléculas provenientes de células vivas? ¿O será necesario que las empresas interesadas en desarrollar este tipo de medicamentos inviertan más capital y tiempo en educar a las autoridades y al público sobre los procesos de desarrollo y beneficios de éstas terapias?

Lea el artículo sobre la decisión de la Corte Suprema Estadounidense en patentado de ADN aquí: http://www.nytimes.com/2013/06/14/us/supreme-court-rules-human-genes-may-not-be-patented.html

It’s not been a good couple of years for Alzheimer’s research. Recently, Baxter’s Gammagard joined J&J and Pfizer’s iv bapineuzumab and Eli Lilly’s solanezumab in a list of late-stage failures. Now, Lilly has voluntarily stopped a phase II trial of another of its Alzheimer’s disease drug candidates. This time, it was the company’s beta secretase 1 (BACE-1) inhibitor, LY2886721, that was given the axe.

Through inhibition of beta secretase, BACE inhibitors can theoretically prevent the production of beta amyloid. However, rather than the drug not being effective, Lilly say the decision to terminate the study was on the basis of abnormal liver biochemical tests. Perhaps the good news is that Lilly don’t believe that the abnormal liver tests were related to the BACE mechanism, and they retain interest in developing BACE inhibitors in the future. The company say they will further evaluate the data before deciding on their next steps with the drug.

“While stopping this Phase II study for our BACE inhibitor is disappointing, patient safety is of utmost importance to Lilly,” said Jan M. Lundberg, Ph.D., executive vice president, science and technology, and president, Lilly Research Laboratories. “Discovering and developing medicines for devastating diseases like Alzheimer’s is fraught with many challenges, but Lilly’s 25-year commitment to bringing medicines to the millions of Alzheimer’s disease patients who are waiting will not wane.”

Eyes will now be on the results of clinical trials with other BACE inhibitors, including Merck’s MK-8931, AstraZeneca’s AZD3293, Roche’s RG7129, and Eisai’s E2609.

Read our infographic on Alzheimer’s Drug Development in 2013.

The trial was halted at Phase II rather than at Phase III, which would have been much more costly for the company. If you want to know more about the detection, analysis and prevention of adverse drug reactions with case studies, industry experiences and global regulatory coverage of developments, you might be interested in attending the World Drug Safety Congress Europe 2013, 10-12 September 2013, London.

What do you think? When do you think the string of AD clinical trial failures will end? Why not join our discussion on LinkedIn, or leave a comment below. Want more from Total BioPharma? Sign up to our newsletter – it doesn’t cost anything and only takes a few seconds.

According to research, Japan’s pharmaceutical industry is the second largest in the world, worth $89 billion in 2011 or 10% of the world market. The easing of regulatory guidelines, an aging population and a strong product pipeline will provide a strong impetus for continued growth in the pharmaceutical industry.

At BioPharma Asia Convention 2013, Mr Hiroshi Sugii, VP and Head of CMR division Japan & Korea at Novonordisk joined us at the Pharma Trials World Asia and shared with us valuable information on the regulatory affairs in Japan and the drivers for innovation in R&D.

Download the full presentation here >

Key agenda include:
-Latest situation of Japanese Regulatory Affairs
-Understanding the pro-active globalization of Japanese pharmaceuticals for the expansion to emerging markets
-Exploring new business models to achieve organic growth beyond borders
-Case Study: Innovation in R&D for sustainable clinical development

Download the full presentation here >

Interested in joining the 7th annual BioPharma Asia Convention and network with more than 2800 attendees from all over the world? Held in March 2014, BioPharma Asia features 6 conferences in 1 and showcases latest solutions and strategy driving growth across Asia’s biopharma industry.
Check out the website here >

With the blockbuster era on decline and generics on the rise, learn more about the current scenario as well as innovation challenges in India’s pharma industry. Dr Anil Prakeep, President of Medical Affairs and Clinical Research, Ipca Laboratories Limited presented on the topic of “Innovation Challenge- Role of Indian Pharma” during the 10th annual BioPharma India.

Download the full presentation here >

BioPharma India Convention will be held on the 25-26 November 2013 in Mumbai India. It is an industry gathering where Supply Chain, Biologic Manufacturing and Pharma Trials professionals come together to discuss pertinent issues in the India’s pharma industry.
For more information, visit: www.terrapinn.com/biopharmaindia

This is the question we asked ourselves as we brought together the speaking faculty and constructed the programme for the 4th Annual World Orphan Drug Congress in Geneva. As the orphan drug market grows at an enviable rate, the pharmaceutical industry have shifted focus and investments towards more niche disease indications, while biotech successfully commercialising their own pipelines are emerging as leading lights and highly attractive investment opportunities for the wider business community. As a result, we thought it interesting to understand where the next wave of orphan drugs may come from and which developers are driving forward future treatments to rare disease patients.

Utilising the invaluable resources on the European Commission Website and the highly respected portal for rare diseases and orphan drugs at Orphanet, we have compiled the Top 10 pharma and biotech companies with the largest number of orphan drug designations in their pipeline.

Freely download the Top 10 Orphan Drug Pipelines in Europe here.

With over 7000 known rare diseases, and with the European Medicines Agency expecting 150+ orphan drug designations in 2013, the upward trend in orphan drug designations is a great sign for the future treatment of rare diseases. As an industry, we look forward to the translation of this research into treatments and cures. We hope you find the following slides interesting and please feel free to share it with your colleagues.

The top 10 public biotechnology companies in terms of R&D expense forked out $23.81 billion last year (2012), a growth of 14.7% on 2011. As you can see, one biotech company accounted for well over a third of that expenditure (Source: PharmaLive).

The figures come from the 22nd Annual Report: Top 100 Biotechnology Companies, available on PharmaLive.

Roche dominates the board (the figures are for the entire Roche Group) in terms of R&D spend, but the pay-off for the company could be huge with approval of Perjeta (pertuzumab) in the US and EU, and the FDA’s approval of antibody-drug conjugate Kadcyla (transtuzumab entansine).

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What do you think of this list? Are there any surprises? Why not join our discussion on LinkedIn, or leave a comment below. Want more from Total BioPharma? Sign up to our newsletter – it doesn’t cost anything and only takes a minute.

Have orphan drugs found a home? It seems that this is the case for a lot of rare disease therapies being developed, as pharma and biotechs, along with investors, have understood that producing orphan drugs can be a potent money maker.

It all started with the first orphan drug approved by the FDA from Genzyme to treat Gaucher’s Disease and when the company decided to charge an unprecedented $200,000 a year which was covered by insurance. Twenty years later, more drugs were granted orphan designation and consequently more orphan drugs available to patients. One of the reasons why this became a more profitable field is the established accelerated approval based on proving effectiveness through surrogate endpoints.

In this new scenario, the main issue seems to be how accelerated development of orphan drugs affect healthcare costs overall.

The answer lies on the fact that developers can charge high prices for orphan drugs. Therefore, if the government is going to encourage drug makers to produce orphan drugs and put no limits on prices, we will quickly see healthcare costs go even more out of control.

A new system that addresses all rare diseases and orphan drugs stakeholders needs to be discussed and established, especially in the reimbursement field, otherwise developing orphan drugs won’t be a sustainable business anymore. The other factor of course is the development of a copy of the drug – making orphan drugs more affordable through time. Or is it time to take away incentives and encourage developers to discover expanded indications like Novartis does?

What do you think?

With over 7000 known rare diseases, the opportunities both in a healthcare and commercial context are tremendous. This eBook holds key insight and top tips about how to overcome development challenges, how to establish fruitful strategic partnerships, what needs to be displayed to payers to demonstrate value and what the foreseeable game changers and opportunities may be that will affect the future of the industry. The feedback was assembled following several interviews conducted with confirmed speakers for the World Orphan Drug Congress Europe 2012.

Download the Top Tips here in our latest eBook here

The speaker faculty for the 4th Annual World Orphan Drug Congress is being finalised this month and so far there has been unprecedented interest and endorsement from the global biopharma and rare disease industry. Take a look at the sponsoring organisations here and book today to get involved with the leading figures of the orphan drug industry, expand your rare disease network and share ideas to create new solutions to meet your business objectives in this space.

For more updates on Pharma, biotech and R&D, follow us on Twitter: @biopharmaevents or join our LinkedIn group: BioPharma- Networking for Pharmaceuticals, Biotech and R&D

There’s been a lot of excitement about PD-1 antibodies in melanoma recently, and data published in the past few days reveals that this excitement is not at all unfounded. But it’s not just the therapeutic potential that is causing a stir. According to Reuters, the market potential of the drugs is also expected to be huge.

The PD-1 drugs work by inhibiting a receptor called programmed death 1 (PD-1), an immune “checkpoint” receptor found on T cells. Tumours can produce a protein called PD-L1, which can bind to PD-1 and make the T-cells inactive. PD-1 therefore allows tumour cells to establish a “molecular camouflage”. By blocking PD-1, monoclonal antibodies can enhance T-cell responses to attack cancer cells.

Several big pharmaceutical companies are pitting their PD-1 antibodies against each other in a race to be first to market. Here are 3 monoclonal antibodies in contention:

Lambrolizumab (MK-3475) – Merck

• Interim data published in New England Journal of Medicine, and presented at ASCO this weekend, showed (press release):
• Overall response rate (percentage of patients who experienced tumour shrinkage) was 38%, out of 135 patients with advanced melanoma
• In a subset of patients at the highest dose, the response rate was 52%
• “Based on these data and additional findings from our ongoing studies, Merck plans to initiate late-stage clinical trials of lambrolizumab in advanced melanoma, and non-small cell lung cancer in the third quarter of 2013,” said Roger M. Perlmutter, M.D. Ph.D., president, Merck Research Laboratories (press release)

Nivolumab – Bristol-Myers Squibb

• Follow-up findings from the CA209-003 phase I trial showed (OncLive):
• Overall response rate was 31%, out of 107 patients with stage IV melanoma
• In a subset of patients, the response rate was 41%
• Combination of nivolumab with Yervoy (a BMS immunotherapy already on the market) had an overall response rate of 40%, with a subset of patients showing a response rate of 53% (press release)

MPDL3280A – Roche Genentech

• This drug works slightly differently as it doesn’t block PD-1, but rather it blocks PDL-1.
• Overall response rate was 21%, out of 140 patients with non-small cell lung cancer, melanoma, kidney cancer, colorectal cancer, and gastric cancer (Yale News)

Of course, it’s hard to compare the above data to establish which drug is “best”, as you’d be comparing tumour shrinkage across multiple trials. Although the drugs are still in their early stages, the PD-1 drugs seem extremely exciting, and there is understandably a large amount of optimism surrounding their development. With regard to the Merck results, Dr. Antoni Ribas, a professor of medicine at the University of California, Los Angeles, and the senior author of the study, said “This is the most impressive thing I’ve seen in melanoma. We’ve never had something where we’ve had these rates of responses with these minimal side effects.” (NY Times)

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The drugs are projected to reach billions of dollars in annual sales, subject to further testing and regulatory approval, of course. Nivolumab alone is expected to have sales of $1.2 billion in 2017, according to Wall Street analysts tracked by Thomson Reuters Pharma (Reuters). And the PD-1 drugs aren’t just for melanoma, either. According to Reuters, Bristol-Myers has three late-stage clinical trials of nivolumab in melanoma, two late-stage trials in lung cancer and one in kidney cancer, while Merck is studying lambrolizumab in triple-negative breast cancer, head and neck cancer, bladder cancer and lung cancer (Reuters).

What do you think? Are you excited by PD-1 antibodies? Do you think they will be the next big blockbusters? Join our discussion on LinkedIn, or leave a comment below. Want more from Total BioPharma? Sign up to our newsletter – it doesn’t cost anything and only takes a minute.

If you want to know more about mAbs, ADCs and next generation technology, you might be interested in attending the 9^th Annual European Antibody Congress 2013, 11-13 November 2013, Geneva.

YOU MIGHT BE INTERESTED IN: The Top 50 Most Influential People in the Antibody Industry

BioPharma India Convention is uniquely positioned as India’s only event where global and regional pharmas, biotechs, CMOs, CROs, investors and other pharma stakeholders come together to asses the latest trends, partnerships and solutions in India. The year’s event includes: an exhibition showcase floor, 3 co-located conferences, one-to-one partnering sessions and an online meeting system. It will take place at Hyatt Regency, Mumbai, India on the 25th and 26th November 2013!

Pharma Trials World India is the leading clinical event for pharmas, biotechs, CROs and solution providers to discuss drug development offshoring and outsourcing opportunities in India. This conference discusses on the following issues:

• Clinical partnerships in India
• Regulatory challenges in India
• Operational excellence in clinical trials
• Effective clinical data management
• Pharmacovigilance for clinical trials

Click here to download the full Pharma Trials conference programme. You can also visit our website for more information!

For speaking or exhibiting opportunities, kindly contact Gladys Leong at +65 6322 2705 or gladys.leong@terrapinn.com today!