PHARMA DEALS DURING NOVEMBER 2014
(Part 2 out of 3)
by Bridget Lacey
Flavour of the month
The therapeutic area of the year continues to be CAR-T (chimeric antigen receptor therapy). Leading the way this month is J&J's Janssen striking a deal with Transposagen Biopharmaceuticals to collaborate over the next three years on new CAR-T drugs; re-engineering T cells to include a chimeric antigen receptor so they can zero in on cancer cells. Along with an unspecified upfront, J&J will pay up to $292 m per treatment in milestones, for all worldwide commercial rights. This month also saw CAR-T “wunder-kid”Juno Therapeutics achieve FDA “breakthough” drug status for its lead compound JCAR015, days after filing for a $150 m IPO. JCAR015, in phase I, showed a "91% complete remission rate in 22 adult patients with relapsed/refractory (r/r) B cell acute lymphoblastic leukaemia (ALL). Historical complete remission rates without JCAR015 in a similar population are less than 10%."
Next steps for this technology will be looking at co-stimulatory domains CD28 and/or 4-1BB and side effects with bi-specific CAR-T looking to minimise off-target activity. Whatever CAR-T's promise, for the time being of course the chronic lymphocytic leukaemia company to beat isPharmacyclics with Imbruvic (ibrutinib), its oral small molecule still proving remarkably resilient to competitor challenges.
As part of its defence strategy Pharmacyclics and its partner J&J continue to collaborate with players across the industry. In October we sawJ&J/Pharmacyclics refresh their deal with BMS and last month the duo announced a collaboration with AstraZeneca (AZ) targeting haematological cancers. AZ has been busy this month and in the deal with J&J, AZ will match its closely-watched PD-L1 checkpoint inhibitor MEDI4736 with Imbruvica. MEDI4736 blocks the signals that help tumours avoid detection by the immune system, countering the tumour's immune-evading tactics. Ibrutinib blocks signals that tell malignant B cells to multiply and spread uncontrollably. Preclinical evidence suggests that their combination may lead to an enhanced anti-tumour immune response. Pharmacyclics will carry out phase I and phase IIa studies, but no financial terms were disclosed.
Whatever it takes
Interestingly, one of the main attractions of AZ for Pfizer was understood to be MEDI4736, as Pfizer wanted a big slice of the immuno-oncology pie, and so instead it has struck a deal with Merck KGaA. This deal gives Pfizer co-development and co-marketing rights to MSB0010718C, Merck KGaA's anti-PD-L1 programme in phase II. In securing this deal, perhaps as a sign of its desperation, Pfizer is paying a staggering $850 m (the largest upfront in the industry's history, a title previously held by Celgene's $710 m payout to Nogra for commercial rights on its Crohn's drug) and up to $2 bn in milestones. In addition to launching combination studies using their existing cancer therapies, the companies will work together to push Pfizer's preclinical anti-PD-1 antibody into phase I. In addition Merck KGaA also gets the right to co-promote Xalkori in the US and other "key" markets.
In another approach to building an oncology powerhouse, AZ has acquired diagnostics company, Definiens, for an initial $150m with a series of undisclosed milestones. AZ plans to use Definiens' technology to develop better biomarkers for cancer to identify well-defined groups of cancer patients, thereby cutting the time and cost of new drug development through its highly precise predictive and prognostic biomarker testing.
AZ also announced a strategic alliance with ISIS Pharmaceuticals building on an existing collaboration between the companies, in the area of antisense oligonucleotide-based therapeutics and RNA biology. Initial project areas will be oncology and cardiovascular and metabolic diseases.
Good news at last
Days after finally getting the FDA's go-ahead to resume development of its lead candidate, imetelsta, for myelofibrosis and myelodysplastic syndrome,Geron has signed a deal with J&J, for a $35 m upfront and promising up to $900 m on undisclosed development, regulatory and commercial goals. With the two companies aligned, the plan now is to map out phase II studies and begin enrolment in 2015. Separately, the companies are planning to launch an exploratory phase II trial in acute myelogenous leukaemia, to see if they can demonstrate a strong signal.
On a mission
Continuing its trend of helping companies monetise their future income streams, Royalty Pharma is buying royalties in Vertex Pharmaceutical's cystic fibrosis treatments from Cystic Fibrosis Foundation for $3.3 bn in cash. The FDA approved Vertex's cystic fibrosis drug Kalydeco in January 2012. In another similar deal, PDL Biopharma acquired the 75% of the University of Michigan's worldwide royalty interest in Cerdelga (eliglustat) for $66 m. Cerdelga, an oral therapy for adult patients with Gaucher disease type 1, was developed by Genzyme and approved by the FDA in August this year. It is currently under review by the EMA and other regulatory authorities. These transactions are seen as part of a growing trend in philanthropy called mission investing; instead of giving research grants, philanthropies act more like business partners and expect a share of profits arising from their gift.
In another interesting deal Gilead Sciences is paying Knight Therapeutics $125 m in cash to buy Knight's priority review voucher (PRV) which can be used to speed up a future filing (from ten months down to six). Introduced by the FDA in 2007, a PRV is an incentive for companies to invest in treatments for neglected tropical diseases. One of 16 tropical diseases that qualify is leishmaniasis, for which Knight's Impavido (miltefosine) was approved in March by the FDA. Gilead has not yet disclosed its intended use for the PRV.
In 2012 the PRV programme was extended to include rare pediatric diseases. BioMarin was awarded a Rare Pediatric Disease PRV when it received approval of Vimizim, a new biological product for patients with Mucopolysaccharidosis type IVA. In July, BioMarin sold its PRV to Regeneron for $68m to expedite filing of its cholesterol drug, the PCSK9 inhibitor alirocumab, being developed in partnership with Sanofi. Selling PRVs is a relatively new area and so these two deals provide initial benchmarks, however it will be interesting to see how future PRV valuations develop.
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