The Friday Five – 5 questions raised this week in pharma

Testosterone growth | HCV in driver's seat | Plegridy's place for Biogen Idec | Relief for Gilead | Roche's next Genentech

What impact is the sex hormone hubbub having?

In light of next month's FDA panel meeting to discuss adverse effects of testosterone replacement therapies, FirstWord ran a poll of urologists in the US and Europe this week to take their temperature on what, if any, impact the debate about possible safety signals is having on usage in patients with hypogonadism (or Low T).

The results suggest doctors on both sides of the pond are aware of the debate, though thus far the controversy seems to have having little impact on their prescribing habits, which have maintained a slow but consistent uptick in scrips over the past year or so.

Interestingly, the impact of the planned advisory committee meeting on September 17, along with the announcements from the FDA that testosterone therapies would add a warning about the risk of blood clots, appear to be having a more significant impact on doctors in the US, where 35 percent of respondents said the number of men treated for Low T is a little too high.

On the other hand, opinions in the EU opinions suggested 33 percent of doctors said not quite enough men were being treated. (See – Physician Views Poll Results: Urologists wary about CV concerns, but not letting it deter increased use of testosterones.)

What is driving biopharma growth?

The list of the biggest growth driver for 1H14 versus the same period in 2013 is an indication of just how big the hepatitis C marketplace is as drugs to treat the viral disease took the top two slots overall based on the success of Sovaldi from Gilead Sciences and Olysio from Johnson & Johnson.

Sovaldi has demonstrated $5.8 billion growth, which blew all of its rivals out of the water across the board, while Johnson &Johnson's Olysio came in second with $1.2 billion in growth. (See FirstWord Lists – Pharma's biggest growth driver drugs during H1 2014.)

Though not at the head of the pack, autoimmune drug Humira continues to generate strong sales ($1.1 billion in growth), followed by a breakout success for multiple sclerosis drug Tecfidera from Biogen Idec and the anti-coagulation agent Xarelto from Bayer and Johnson & Johnson.

Roche's focus on oncology looks to be playing out as expected thanks to its continuing push for two of its stalwarts in Avastin and Herceptin, while simultaneously finding increased traction with Perjeta and Kadcyle.

Notably absent from the list of key growth drivers are several products from GlaxoSmithKIine, including HIV drug Tivicay that got left just outside those shown and the company's Breo Ellipta and Anoro Ellipta franchises, which have experienced a relatively disappointing launch thus far.

How important will Plegridy become to Biogen Idec's bottom line?

Plegridy became the newest addition to Biogen Idec's impressive multiple sclerosis arsenal last week after it gained approval from the FDA, though analysts suggest the twice-monthly injectable interferon is more important to the company's long-term strategy.

While Biogen Idec's launch with Tecfidera has been beating analyst numbers on a quarterly basis, some questions have arisen about whether the success of the oral MS drug might cannibalise sales of the company's injectable interferon franchise led by once-weekly Avonex.

Plegridy represents an important defence against the long-term degradation of this franchise because the drug's convenience and thus adherence advantages should precipitate a substantial amount of switching from Avonex, thus negating the impact from the overall decrease in use of injectable products.

Indeed, a poll of 81 neurologists conducted by FirstWord this spring offers reason for optimism, as 44 percent of respondents indicated the availability of Plegridy would "slightly" increase the percentage of first-line patients prescribed an interferon drug. (See Physician Views Poll Results: Biogen Idec's Plegridy points to longevity of interferons in MS market despite oral revolution.)

Is Gilead now home-free on Sovaldi-related litigation?

Investors managed a small but significant sigh of relief this week after an arbitration case brought by Roche came down in Gilead's favour, thus removing a small but important overhang related to a dispute over the rightful owner of HCV blockbuster Sovaldi.

After buying Pharmasset in 2012 for $11 billion, Gilead is expected to be in the black on the deal by the end of this year based on analyst forecasts, which suggest the company will record as much as $12 billion in 2014 sales of Sovaldi.

The eye-popping figures have predictably attracted interest from all quarters, including both competitors developing new regimens and litigants looking for a piece of the action. Among a number of companies to be pursuing legal actions, analysts believe that Roche may have had the strongest case based on its argument that a partnership with Pharmasset extending back to 2004 may have given it rights to Sovaldi.

Roche's odds were long, according to Cowen analyst Phil Nadeau, but not zero.

Thus Gilead shareholders were happy to hear that an arbitrator ruled Roche was unable to establish any of its claims and is thus entitled to no damages in the case, an unambiguous win for Gilead and perhaps a bad sign for other companies pursuing a litigious strategy, including AbbVie and Merck & Co. (see ViewPoints: Sigh of relief for Gilead as a small but real risk of disaster is averted in Sovaldi arbitration).

Roche rumoured to be interested in buying the rest of Chugai – but why now?

Rumours are swirling that Roche is looking to buy the 38 percent of Chugai that it doesn't already own, but because the Swiss drugmaker already owns a controlling stake the question is why now?

Analysts speculate that there could be some purely financial incentives for Roche wanting to consummate the deal, with JP Morgan analyst Richard Vosser suggesting it could be in line for 2 percent accretion based on annual savings from R&D and SG&A alone.

Others, including Morgan Stanley analyst Shinichiro Muraoka, believe there may be more than just financial engineering on Roche's mind if it is indeed making a play based on the maturation of the Japanese company's pipeline. Muraoka, who upgraded Chugai to overweight from equal weight in July based on the emergence of several new drugs, noted that approval of ALK inhibitor Alecensa is expected in Japan this year, and in the US in 2015, with Roche-based sales expected to top $1 billion. Other programmes with potential upside include ACE910, a longer-acting haemophilia product in Phase I/II testing, as well as some immuno-oncology assets.

Thus, the next question may be how much Roche is willing to pay for Chugai given both its tendency to be very patient in stalking potential takeouts and the unlikelihood of a competitive bid given the Swiss company's ownership of a controlling stake (see ViewPoints: What might be driving Roche's reported interest in Chugai?)

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