Government announces boost for local pharmaceutical sector

An interesting article from Espicom’s  World Generic Markets business publication.

On 13th April 2012, South Africa’s Department of Trade and Industry and Department of Health jointly announced the designation of certain pharmaceutical products for domestic production.  The government bodies commented that the designation was in line with the amended Regulations to the Preferential Procurement Policy Framework Act (PPPFA), which were promulgated in 2011 and make provision for designation by the Department of Trade and Industry of sectors, sub-sectors and industries identified in national economic development and industrial policies, for the procurement exclusively from domestic manufacturers.

The departments commented that South Africa has one of the worst disease burdens; consequently, it is important to ensure supply security and development of local capacity.  The designation of the pharmaceutical products would thus benefit the country both in terms of health and economy.  The designation includes the oral solid dosage tender worth over R2.5 billion (US$318.3 million) over two years.  The potential list of more than 70 pharmaceutical products is being finalised.

The intention behind the announcement is to create security of demand for domestic production, attract foreign and domestic investment and to further industrialise South Africa’s economy.  The Trade and Industry Minister, Dr Rob Davies, noted that the pharmaceutical sector is the fifth largest contributor to South Africa’s import burden, and commented that reversing this was an important challenge, whilst still ensuring that affordable healthcare is available to the public and private sectors.

According to Dr Davies, prices will be benchmarked internationally and local manufacturers will have to ensure that the benchmark is not exceeded to quality, thus ensuring that medicine prices remain affordable.  The minister added that for security of supply purposes, the government would still continue to source some of its medicines from importers.

Commenting on the announcement, Adcock Ingram said that it welcomed the move.  The firm commented that it took the view that a greater alignment between industrial policy and government procurement was critical for ensuring a sustainable pharmaceutical manufacturing base in South Africa.  Adcock argued that the move would also have a significant effect on patient access to affordable medicines.  In addition, as the local manufacturing base grows through increased capacity utilisation and the attainment of economies of scale, so South African manufacturers would be well placed for global competition and export potential.

Article source: Ian Platts. Editor of Espicom’s business publication World Generic Markets

Amgen and AstraZeneca have entered into an agreement to jointly develop and commercialise the following five monoclonal antibodies from Amgen’s clinical inflammation portfolio:

• brodalumab (AMG 827), which binds to and blocks signalling via the interleukin-17 receptor, is being investigated for psoriasis (completed Phase II and planned Phase III), psoriatic arthritis (Phase II) and asthma (Phase II);

• AMG 139 is in Phase Ib for Crohn’s disease;

• AMG 181 is in Phase Ia and Ib trials for ulcerative colitis and Crohn’s disease;

• AMG 557, which binds to B7-related protein 1, is in Phase Ib for autoimmune diseases such as systemic lupus erythematosus; and

• AMG 157, which blocks interaction of thymic stromal lymphopoietin with its receptor, is in Phase Ib for asthma.

The collaboration will provide Amgen with additional resources to optimally progress its portfolio, and Amgen will benefit from the strong respiratory, inflammation and asthma development expertise of MedImmune, AstraZeneca’s biologics arm. The collaboration will also capitalise on AstraZeneca’s global commercial reach in respiratory and gastrointestinal diseases. The agreement does not include certain territories previously partnered by Amgen for brodalumab with Kyowa Hakko Kirin and AMG 557 with Takeda.

Under the terms of the agreement, AstraZeneca will make a one-time US$50 million up-front payment, and the companies will share both costs and profits. Based on current plans, approximately 65 per cent of costs for the 2012 to 2014 period will be funded by AstraZeneca. Thereafter, the companies will split costs equally. Amgen will book sales globally and retain a low single-digit royalty for brodalumab and a mid-single-digit royalty for the rest of the portfolio, after which the companies will share profits equally.

AstraZeneca will lead the development and commercial strategy of AMG 139, AMG 157 and AMG 181, while Amgen will lead the development and commercial strategy of brodalumab and AMG 557. Each development and commercialisation lead will be under the oversight of joint governing bodies. For brodalumab, commercial promotion will be split. Amgen will promote in dermatology indications in the US and Canada, and in rheumatology indications in the US, Canada and Europe. AstraZeneca will promote in respiratory and, initially, dermatology indications of brodalumab across all territories outside of the US, Canada and those markets where Amgen has existing partnerships. Allocation of promotional rights for other territories, indications and molecules will be agreed later between the companies.

Spectrum Pharmaceuticals has seen mixed fortunes recently

….On the positive side, the company is seeking to strengthen its position in the haematology area and has agreed to pay up to US$206 million, plus additional consideration if certain milestones are met, for Allos Therapeutics. On the downside, its lead compound, apaziquone, has failed to meet the primary endpoint of a statistically significant difference in the rate of tumour recurrence at two years in both Phase III trials investigating it for the treatment of non-muscle-invasive bladder tumours. Spectrum had expected to file an NDA for apaziquone in 2012.

However, it might not be all bad news for this drug, as an analysis of the pooled data from both studies showed a statistically significant treatment effect in favour of apaziquone in the primary endpoint and a key secondary endpoint. Thus, Spectrum is currently weighing up its options on whether to proceed with this drug in the future.

Spectrum share price takes a hit

On the back of this mixed news, Spectrum’s share price tumbled by 9.4 per cent from US$12.21 to US$11.06, whereas investors in Allos were more impressed with the takeover news, leading to a rise of 27.3 per cent in its shares from US$1.43 to US$1.82, both at close of day on 4th and 5th April, respectively.

Spectrum currently sells two oncology drugs, Zevalin (ibritumomab tiuxetan), which is approved to treat a form of non-Hodgkin’s lymphoma, and Fusilev (levoleucovorin), which treats the side effects of methotrexate. For 2011, Zevalin sales declined by 4.5 per cent to US$27.6 million, whereas Fusilev posted sales of US$153 million, up from US$32 million in 2010.

The acquisition of Allos, which is expected to be accretive to Spectrum on a cash basis in the fourth quarter of 2012, will bring a new revenue stream in the form of Folotyn (pralatrexate), a novel dihydrofolate reductase inhibitor that was approved by the FDA in September 2009 for patients with relapsed or refractory peripheral T-cell lymphoma. The product generated US net sales of US$50 million in 2011. Allos and Mundipharma have a strategic collaboration to co-develop Folotyn; Allos retains full commercialisation rights in the US and Canada, while Mundipharma has exclusive rights in all other countries. Mundipharma has submitted various applications seeking regulatory approval of Folotyn, including in Australia, South Korea and Switzerland. Unfortunately, in Europe, at its January 2012 meeting, the EMA’s CHMP issued an opinion recommending against conditional approval of Folotyn due to concerns about the study submitted in support of the application.

Rajesh C Shrotriya, Chairman, CEO and President of Spectrum stated: “For Spectrum, this acquisition adds another diversified source of revenue, accelerates the development of our haematology franchise and affirms our commitment to becoming a leader in the treatment of lymphoma. Zevalin and Folotyn are targeted to the same haematologists/oncologists for the treatment of different forms of lymphoma.”

Article source: Cancer Drug News edited by Ros Smallman.

Anti-Infective Drug News Latest

Aeras Global TB Vaccine Foundation has received a grant from the Bill & Melinda Gates Foundation of up to US$220 million over five years, allowing it to expand upon existing partnerships in Europe, Africa, China and around the world, and build new partnerships that will accelerate the development of safe and effective tuberculosis (TB) vaccines.

The funding will advance several vaccine candidates into pivotal large-scale efficacy trials, build a robust and diverse pipeline of innovative, next-generation candidates, and develop and utilise key scientific approaches, including challenge models, systems biology and innovative vaccine designs to strengthen and accelerate TB vaccine development.

Aeras estimates that US$400 million to US$500 million will be needed over the next five years if the organisation is to accomplish critical TB vaccine development goals set jointly with global research and development partners. The grant provides approximately half of the estimated cost of meeting 2012 to 2016 milestone targets, while addressing significant scientific questions that must be answered in order to further the successful development of new vaccines.

In addition…

The Global Alliance for TB Drug Development (TB Alliance) has launched a first-of-its-kind clinical trial to test a novel drug combination in both patients who have TB and those who have multi-drug-resistant TB (MDR-TB).

Currently, someone with ordinary TB must take a course of drugs daily for six months, while those with MDR-TB must take a daily injection for the first six months and a dozen or more tablets each day for 18 months or more. Around the world, many patients fail to complete treatment because they can no longer tolerate the side effects of the medications or cannot adhere to the long treatment, leading to drug resistance, be it MDR-TB, or even extensively DR-TB.

The novel regimen being tested could shorten the length of required treatment to as little as four months in both patients with TB and some forms of DR-TB. For those drug-resistant patients, this completely oral regimen could reduce treatment time by more than 80 per cent, increase the efficacy of treatment and cost just a fraction of current MDR-TB treatment.

The Phase II trial builds on the TB Alliance’s two-week New Combination 1 (NC-001) trial initiated in 2010, which was the first study to test novel TB drugs in combination. The newly-launched trial, New Combination 2 (NC-002), advances the regimen of new TB drug candidates, PA-824 and moxifloxacin, in combination with pyrazinamide, an existing antibiotic commonly used in TB treatment. NC-002 will treat patients for two months, take place at eight sites in South Africa, Tanzania and Brazil, and advance global capacity for TB trials along with the new innovative approach to TB drug development.

Cancer Drug News Update

Newly-released figures estimate that there will be 1,283,101 deaths from cancer in 2012 in the EU: 717,398 men and 565,703 women. Although the actual numbers have increased, largely as a result of the EU population ageing, the rate (age-standardised per 100,000 population) of people who die from the disease continues to decline.

Writing in the 28th February online issue of the Annals of Oncology (10.1093/annonc/mds024), researchers from the University of Milan and University of Lausanne have estimated that the overall cancer death rates will be 139 per 100,000 men and 85 per 100,000 women in 2012. Compared with confirmed deaths in 2007 (the year for which there are World Health Organization mortality data for most EU countries), this represents a fall of 10 per cent in men and 7 per cent in women. The falling rates are due to a decline in men smoking, and to progress in cancer prevention, early detection and treatment, according to the authors.

The study looked at disease rates in all 27 EU member states and also in six individual countries (France, Germany, Italy, Poland, Spain and the UK) for all cancers, and, individually, for stomach, intestinal, pancreatic, lung (LC), prostate, breast (BC), uterus (including cervix), plus leukaemias.

One of the key findings is that there will be substantial reductions in deaths from BC, not just in middle-aged and older women, but also in the young. The researchers predict a 9 per cent drop in BC deaths, corresponding to a rate of 14.9 per 100,000 women. Among young women, aged 20 to 49 years, the drop is greater, at just over 13 per cent, corresponding to a rate of 6.3 per 100,000 women. BC remains the leading cause of female cancer deaths in the EU as a whole, including in France, Germany, Italy and Spain: 88,000 women will die from it in 2012, corresponding to almost 15 per cent of all cancer deaths in EU women.

However, in the UK and Poland, LC is the leading cause of cancer death among women, with rates of 21.4 and 16.9 per 100,000 women, respectively. In the EU as a whole, deaths from LC continue to increase among women, with an overall rate of 13.4 per 100,000. However, although it is the leading cause of cancer death in men, at 37.2 per 100,000, this represents a 10 per cent decline from 2007 when the death rate was 41.3 per 100,000. Rates will be highest in Poland at 56.8 per 100,000, and lowest in the UK at 30.1 per 100,000 men.

Rates of pancreatic cancer are rising among both men and women in the EU as a whole; up from 7.86 in 2007 to 8.01 per 100,000 in men, and from 5.24 to 5.38 per 100,000 in women.

In 2003, the European Code Against Cancer set a target to reduce cancer deaths by 15 per cent by 2015, however, the current researchers believe that this target may be achieved in 2012.

Article source: Cancer Drug News, edited by Johanna Shiu.

Introducing Espicom Interactive – Espicom’s new online delivery platform

Welcome back to Pharmaceutical News. Today we have some exciting news, the launch of our new service Espicom Interactive.

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Field staff and agents worldwide will benefit from machine translation into 9 languages, which cover key emerging markets such as Brazil and China. Watch the instructional video below to assess the power and versatility of the Espicom Interactive platform.

Espicom Interactive Instructional Video

For many companies the cost of business information represents a significant investment. Its practical use in defining commercial strategy and in understanding market environments is critical to success. However, the value of such investments is only really beneficial if the service empowers staff to greater efficiency in its use. Business information should be a support to effective decision making and not a burdensome administration task.

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This Weeks Cancer Drug News

The past week’s news has been dominated by a couple of major proposed acquisitions, plus FDA approvals for two new drugs for the treatment of abasal cell carcinom (BCC) and renal cell carcinoma (RCC).

Amgen

Firstly, Amgen has signed a definitive merger agreement to acquire Micromet for approximately US$1.16 billion. Micromet was founded in 1993 by a team of scientists from the University of Munich with a firm belief in the potential of T-cell-based therapies to treat cancer. The company has demonstrated the clinical potential of its technology, referred to as bi-specific T-cell engager (BiTE), with the publication of results from a Phase I trial of its BiTE antibody, blinatumomab, in patients with non-Hodgkin’s lymphoma. Headquartered in Rockville, MD, with a research facility in Munich, Germany, Micromet is now an integrated biopharmaceutical company with a pipeline of promising drug candidates, a clinically-validated technology platform and strong BiTE antibody partnerships with industry leaders.

Celgene

Also looking to boost its pipeline is Celgene, which has agreed to buy Avila Therapeutics for up to US$925 million. Avila is pioneering a method to discover and develop new small-molecule drugs that achieve protein silencing to create highly-effective therapies for a broad range of diseases. It is developing a pipeline of novel, targeted covalent drugs with a current focus on cancer, autoimmune diseases and hepatitis C. Avila is able to silence the activity of disease-causing proteins by selectively forming strong and durable covalent bonds. While there are approved covalent drugs that arose from serendipitous discovery, Avila is the first company to design and develop targeted covalent drugs robustly, systematically and across the vast majority of target classes. This is enabled by its proprietary Avilomics platform.

For US patients with BCC or RCC, the FDA approval of two new groundbreaking drugs will come as welcome news. Approval of Pfizer’s Inlyta (axitinib) for the treatment of advanced RCC after failure of one prior systemic therapy was based on data showing that it produced a median progression-free survival of 6.7 months compared with just 4.7 months for sorafenib, the current standard-of-care. Inlyta is the first targeted therapy to be approved in the US for this indication. The product adds to the company’s portfolio of treatment options for RCC patients, which also includes Sutent (sunitinib) and Torisel (temsirolimus).

Genentech’s (Roche)

Genentech’s (Roche) Erivedge (vismodegib), which was developed in collaboration with Curis, has gained approved for the once-daily treatment of adults with BCC that has metastasised or recurred following surgery, or that their healthcare provider decides cannot be treated with surgery or radiation. This first-in-class Hedgehog pathway inhibitor is the only FDA-approved medicine for people with advanced forms of BCC. This is the second skin cancer drug that Genentech has gained approval for in the last six months, following the August 2011 clearance of Zelboraf (vemurafenib) for the treatment of BRAF V600E mutation-positive, inoperable or metastatic melanoma.

Article source: Cancer Drug News, edited by Johanna Shiu.

Neuro Drug Focus

End of 2011 sees mixed results

Within the glut of end-of-year news was a set of mixed late-stage results, including Trophos reporting data from a Phase III study of olesoxime (TRO19622) in patients with amyotrophic lateral sclerosis (Lou Gehrig’s disease). Unfortunately for the company, olesoxime did not demonstrate a significant increase in survival versus placebo in patients receiving riluzole and following receipt of these results, Actelion has decided not to exercise its option to acquire Trophos.

Targacept & AstraZenca-

Elsewhere, the news was also negative for Targacept, which, together with AstraZeneca, reported top-line results from RENAISSANCE 2, the second of four RENAISSANCE Phase III studies investigating the efficacy and tolerability of TC-5214 as an adjunct therapy to an antidepressant in patients with major depressive disorder who do not respond adequately to initial antidepressant treatment. The study did not meet its primary endpoint and these results follow the failure of RENAISSANCE 3 to also meet its primary endpoint. The previous news was enough to see Targacept’s share price dive by 60 per cent, from US$19.12 to US$7.61 at close of day on 7th and 8th November, respectively, and as of close of day on 3rd January, the price stood at US$5.62.

Genzyme (Sanofi)

Genzyme (Sanofi) also reported top-line results from TENERE, a Phase III trial comparing once-daily oral Aubagio (teriflunomide) to interferon beta-1a (IFN beta-1a) in people with relapsing forms of multiple sclerosis (MS). This is the second completed study of five efficacy trials of teriflunomide in MS. No statistical superiority was observed between the Rebif (IFN beta-1a) and teriflunomide arms (7 and 14mg) on risk of treatment failure, the primary composite endpoint. In the study, 48.6 per cent of patients receiving 7mg of oral teriflunomide (n=109) and 37.8 per cent of those receiving 14mg (n=111) reached the primary endpoint, versus 42.3 per cent receiving Rebif (n=104). The teriflunomide 14mg daily dose (0.259) and Rebif (0.216) were not distinguishable on the endpoint of estimated annual relapse rate; the rate was higher in the 7mg arm (0.410).

SYGNIS Pharma

Also of note, SYGNIS Pharma reported key results of its Phase II trial of AX200 (G-CSF) to treat acute ischaemic stroke. The data on the relevant primary endpoint, using the modified Rankin Scale, and secondary endpoint, using the National Institutes of Health Stroke Scale, showed no improvement in patient outcome relative to the placebo-treated patient. As a result, the study missed its endpoints.

Novartis

Meanwhile, Novartis reported new data from the Phase III 2309 study showing that patients with relapsing-remitting MS treated with Gilenya (fingolimod) had a statistically significant 48 per cent reduction in annualised relapse rates at 24 months compared to placebo. In addition, a Phase III study of Lyrica (pregabalin) in patients with restless legs syndrome (RLS) met each of its three co-primary endpoints, showing significant benefit as compared with placebo and pramipexole; Pfizer will continue to further analyse these top-line results, but at present, does not have plans to seek regulatory approval for an indication in RLS. As for the companies reporting negative results, the full impact on their development and commercialisation plans may not yet be evident, with their futures involving further analysis of the data or awaiting the outcome of other trials.

Article source: Neuro Drug Focus from Espicom Business Intelligence

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Major PCA Variant Pinpointed

Oncology developments a mixed bag in 2011

A team, including researchers at the University of North Carolina (UNC), Chapel Hill, Johns Hopkins University (JHU), University of Michigan, Wake Forest University and Translational Genomics Research Institute, has identified a rare, inherited mutation linked to a significantly higher risk of prostate cancer (PCA). The investigators looked for the same HOXB13 gene mutation among 5,100 men who had been treated for PCA; the mutation was found in 72 (1.4 per cent). These men were much more likely to have at least one first-degree relative who also had been diagnosed with PCA. The team also looked for the mutation in a control group of 1,400 men without PCA and only one of those carried the mutation. Men who were specifically enrolled in studies of early-onset or familial PCA were also studied.

Ethan Lange, UNC Chapel Hill Associate Professor of Genetics and Biostatistics, said that: “There is still work to be done regarding understanding the biological function of the mutation and the precise level of absolute risk for carriers of this mutation, a process that took years for the BRCA1 and BRCA2 genes. Still, our results strongly suggest this is the most clinically-important mutation identified for prostate cancer, to date”.

This particular mutation was found in families of European descent, while two different mutations on the HOXB13 gene were identified in families of African descent. An estimated 241,740 new cases of PCA will occur in the US during 2012, however, for reasons that remain unclear, incidence rates are significantly higher in African-Americans than Caucasians (241:100,000 vs 149:100,000 in 2008). Although death rates have decreased more rapidly among African-American than Caucasian men, rates in African-Americans remain more than twice as high as those in whites. Since only seven of the 94 families studied were of African descent, more research will be required before the significance of the mutations is known. James P Evans, Bryson Distinguished Professor of Genetics in the UNC School of Medicine, observed: “The genetics of prostate cancer have proven surprisingly difficult to unravel and this work represents significant and welcome progress. While fewer than 1 per cent of Caucasian men carry the described mutation in this particular gene, for those men who do carry it, the increased risk for developing prostate cancer is likely greater than for any previous mutation found, to date. Larger follow-up studies will be necessary to understand the importance of this finding for prostate cancer, and it remains to be seen whether this mutation is associated with other cancers”.

“It’s what we’ve been looking for over the past 20 years,” added Dr William B Isaacs, Professor of Urology and Oncology at the JHU School of Medicine. “It’s long been clear that prostate cancer can run in families, but pinpointing the underlying genetic basis has been challenging and previous studies have provided inconsistent results”. Indeed, the most recent data concerning PCA genes prior to this were presented in February 2011 from a PCA gene identification study by Genomic Health, which identified 295 genes strongly associated with clinical recurrence following radical prostatectomy with great consistency, but did not link these findings to any specific inherited mutation.

Article source: Cancer Drug News edited by Emily Halterman

Cancer Drug News

The start of 2012 has begun positively for a number of companies that have raised millions in order to continue developing their promising new technologies and compounds.

Midatech

Midatech, which is at the forefront of designing, developing, synthesising and manufacturing nanomedicines based on its proprietary, self-assembling biocompatible nanoparticle technology, has raised £6.3 million. Midatech’s nanomedicine development programmes focus on oncology, including traditional onco-drugs and si/shRNA drugs; and metabolic disorders, including diabetes. The company’s advanced development plans focus on vaccines, including prophylactic vaccines, and immunotherapy for cancer and chronic viral disorders.
Senesco Technologies has entered into a securities purchase agreement to raise approximately US$2 million in gross proceeds. This cancer therapeutics company is employing its proprietary platform in eukaryotic translation initiation Factor 5A (eIF5A) technology to regulate cell death and survival. Its lead therapeutic candidate, SNS01-T, incorporates recent developments in siRNA, DNA regulation and nanotechnology. Senesco is building its portfolio with other potential eIF5A applications in cancer, inflammation and ischaemia.

BerGenBio

BerGenBio is a biotechnology company built on proprietary screening technology used for the research and preclinical development of novel drug targets, associated biomarkers and first-in-class therapeutics for the treatment of cancer, with lead programmes against metastatic drug-resistant solid tumours, epithelial-mesenchymal transition and drug resistance. The company has completed an US$8.8 million series A financing round that will be used primarily to take BGB324 into clinical trials and develop a companion diagnostic.

Apogenix

Apogenix is developing novel protein therapeutics for the treatment of cancer and inflammatory diseases. It was founded as a spin-out from the German Cancer Research Center and since its inception in autumn 2005, has raised more than EUR 50 million in three financing rounds. In addition, it has been awarded public funds totalling nearly EUR 8.5 million. Apogenix has now completed a EUR 7.5 million financing round to further advance the Phase II trial of APG101 to treat glioblastoma multiforme and other cancer indications.

Pharmalink

Pharmalink, which has raised SKr 35 million, is a specialty pharmaceutical company that is developing high-value products for niche indications. Using a repurposing and reformulation strategy, the company minimises the risk of product development. Its strategy is to apply its expertise to drive drug development and commercialise with partners. To date, Pharmalink has introduced more than 15 pharmaceutical products to the market. The new funds will be used to further advance its two lead product candidates, including Busulipo (busulfan).

The ability of these companies to raise capital in the current difficult economic climate reflects the potential of their product pipelines, and the confidence that investors have in them and their strategies.

Article source: Espicom business publication Cancer Drug News

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