Alex Philippidis Senior News Editor Genetic Engineering & Biotechnology News

Drug sanctions mark new options for lupus and melanoma, while Amgen and Daiichi saw success with business expansion.

This month last year key biotech news included FDA’s approval of two mAb therapeutics, Benlysta and Yervoy; Amgen’s efforts to expand indications for its cancer drug Vectibix in Europe; and Daiichi Sankyo’s announcement of an up-to-$935 million acquisition of Plexxicon. All three announcements made headlines, representing milestones in drug development and important strategic moves to improve business.

The drug sanctions marked the first in their respective indications of lupus and melanoma in several years. Amgen’s regulatory activities in the EU were a push to be able to market Vectibix as a first-line therapy for metastatic colorectal cancer (mCRC), thus bolstering the Vectibix franchise. And Japanese firm Daiichi made its purchase with an eye to fortify its U.S. presence. These developments are important today because over the past year each has generated even more news.

Benlysta, Yervoy Enter Market

Two drugs approved by FDA this month last year have made successful debuts. One of them was Benlysta (belimumab), a systemic lupus erythematosus (SLE) treatment developed by Human Genome Sciences (HGS) and GlaxoSmithKline (GSK). Benlysta finished 2011 with $52 million in sales, accounting for about 40% of HGS’ total sales of $131 million last year.

HGS and GSK co-developed Benlysta under a 2006 agreement. The companies shared equally in Phase III/IV development costs, sales, and marketing expenses as well as profits. Sales growth has been steady, from $8 million in Q2 to $18 million in Q3, to $26 million in Q4, helped in part by EC’s sanction of Benlysta last May. More importantly, Benlysta’s success positions HGS toward profitability for the first time since it was founded in 1992.

“HGS remains committed to achieving profitability in 2014,” CEO H. Thomas Watkins told analysts February 27 on a conference call. During that call, Barry Labinger, evp and chief commercial officer with HGS, trumpeted a new market study that found in part that three-quarters of patients treated with Benlysta showed improvement in at least one aspect of the disease.

Benlysta’s March 9, 2011, approval came on the back of two Phase III studies involving 1,684 patients showing that the drug reduced SLE activity. Still, the agency limited its indication by not recommending Benlysta for patients with severe active lupus nephritis or severe active central nervous sytem lupus, or in combination with other biologics or intravenous cyclophosphamide.

Also finding success over the past year was Bristol-Myers Squibb’s mAb therapeutic Yervoy for late-stage metastatic melanoma. Two Phase III studies—one completed after approval—showed a significant overall survival benefit. The drug also won EC approval in July, after which it was launched in Germany and some other countries on the continent, “while we are working through the process of access and reimbursement in the rest of the region,” Lamberto Andreotti, BMS’ CEO, told analysts on a January 26 conference call. Charlie Bancroft, BMS’ CFO, said on the call that the firm expects Yervoy will be commercially available and reimbursed in most of its top eight countries by mid-2012 and in almost all EU countries by the end of 2012.

In Europe as in the U.S., Yervoy is indicated for previously-treated patients whose tumors had spread or could not be surgically removed. Yervoy will need to generate sales overseas, since the U.S. accounted for $118 million of the total $144 million racked up.

“We continue to be encouraged by the performance of Yervoy,” Bancroft said. “Until the introduction of Yervoy and [late stage skin cancer drug] Zelboraf last year, no new agent has been approved for metastatic melanoma in over a decade. The market is now in a state of transition as physicians become more familiar with these new medicines.”

Amgen Wins Vectibix Expansion in Europe

It took most of 2011, but Amgen prevailed in an appeal it filed last March after the EMA recommended against extending the marketing authorization of mAb-based drug Vectibix to include combination with chemotherapy for the treatment of patients with wild-type KRAS metastatic colorectal cancer (mCRC).

Previously, Vectibix had received conditional approval in the EU as monotherapy, which was revised to state that the drug was indicated for wild-type KRAS mCRC as monotherapy after failure of fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens. In November 2011, EC changed the marketing authorization to first-line treatment of wild-type KRAS mCRC in combination with FOLFOX and as a second-line therapy in combination with FOLFIRI in patients who have received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan).

The expanded European indication should further boost Vectibix sales outside the U.S. According to Amgen, Vectibix sales rose 12% last year to $322 million from $288 million. U.S. sales rose 6% from 2010 to $122 million in 2011.

Vectibix first entered the U.S. market in 2006 after winning an accelerated priority review. It was approved for epidermal growth factor receptor (EGFR) -expressing mCRC in patients with disease progression on or following fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens. Vectibix is one of two anti-EGFR antibodies approved by the agency; the other is mAb therapeutic Erbitux approved in 2004 and marketed by BMS, Merck Serono, Merck & Co., and Eli Lilly.

Amgen spokeswoman Christine Regan told GEN the company is still under FDA review where Vectibix is concerned, however, on its first- and second-line mCRC sBLA, originally filed in late 2010. On July 29, Amgen disclosed that it received complete response letters seeking an updated safety analysis and additional analyses of the overall survival data in two studies using more mature datasets. At the time FDA also said that it would grant approval for the first- and second-line indications contingent upon approval of a companion KRAS diagnostic device, which is already under development with Qiagen.

Daiichi’s Plexxicon Takeover Shows Results

When Daiichi Sankyo snapped up Plexxicon last year, it was speculated that Japan’s third-largest drug company was looking to quickly enter the U.S. cancer drug market; number-two Astellas in 2010 shelled out $4 billion for OSI Pharmaceuticals. Specifically, Daiichi was interested in PLX 4032, or Zelboraf, an oral treatment co-developed with Roche for BRAF melanoma; the firms say that the targeted BRAF mutation is present in about half of melanoma cancers and about 8% of solid tumors.

Daiichi agreed to pay Plexxicon $805 million up front plus another $130 million in milestone payments tied to approvals for Zelboraf. The drug’s first go-ahead came in August, when FDA okayed it for patients with BRAFV600E mutation-positive inoperable or metastatic melanoma as detected by an approved test. FDA also approved a companion diagnostic, the cobas 4800 BRAF V600 Mutation Test, making it just one of two drug-diagnostic combos green-lighted last year.

Since then, Zelboraf has won approvals in Switzerland, Israel, Brazil, New Zealand, Canada, and the EU. At the time of the EC go-ahead this February, Daiichi disclosed that marketing authorization submissions for Zelboraf were currently under review by health authorities in other countries including Australia, India, and Mexico.

While Daiichi doesn’t break out per-drug sales figures, the company did credit Zelboraf-related income as helping its North American sales. It wasn’t enough, however, to stem a 4.1% decline down to ¥136.2 billion (about $1.6 billion). In 2011, North America sales accounted for almost 20% of Daiichi’s total sales of ¥696.4 billion (about $8.35 billion); that total was down 6.9% from a year earlier. Daiichi blamed the weak North American results on the strong yen, a sales decline for the antihypertensive agent Benicar, and unspecified other factors.

Daiichi did say that it will include Zelboraf revenue within a “Plexxicon” line in its financial results, according to which Plexxicon accounted for ¥5.1 billion (about $61.2 million) of Daiichi revenue for March–December 2011, the first three quarters of the company’s fiscal year. How long that line will last is uncertain, because under the acquisition, Daiichi agreed to maintain Plexxicon as an independent unit for just two years.

Alex Philippidis is senior news editor at Genetic Engineering & Biotechnology News.

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