Amgen Middle East Regulatory Director On Regulatory Expertise And Drug Pricing - An Interview With PharmAsia News

Amgen is targeting the Middle East as a new growth area, and it plans to venture further into Gulf countries from Saudi Arabia and war-torn Iraq to countries like Algeria and Libya.

Against a backdrop of drug price reductions enforced by governments across the region, the pricing issue has become the single largest regulatory challenge facing Dubai-based Amgen Middle East. Regulatory Affairs Director Adel Djalal spoke with PharmAsia News on the sidelines of DIA's Middle East Regulatory Conference.

PharmAsia News : How long has Amgen been in the Middle East and what does your footprint look like in the region?

Adel Djalal: Amgen established its regional office in Dubai in 2006 and has been in the region for six years. We are currently covering Gulf Cooperation Council [GCC] countries such as Saudi Arabia, United Arab Emirates, as well as Egypt, Morocco and South Africa.

We are supposed to start regulatory filings in Algeria and Libya in 2011, and we have plans for Iraq and Lebanon, where we don't have a presence, in the next one to two years. We will see after that, but we are going. Amgen is really going in the Middle East region.

PharmAsia News : What are some products that you have in the region?

Djalal: The target five products in the region are Aranesp [darbepoetin] for anemia, oncology drug Vectibix [panitumumab], another oncology product Mimpara [cinacalcet]. Two products coming to the portfolio are Prolia [denosumab] and Nplate [romiplostim].

[Editor's note: Vectibix is indicated for metastatic colorectal cancer. Mimpara is indicated for controlling hypercalcemia in patients with parathyroid carcinoma. Prolia is approved in the U.S. for postmenopausal women at risk of osteoporosis. Nplate is indicated for adults with immune idiopathic thrombocytopenic purpura.]

PharmAsia News : Can you discuss how you view Prolia's potential in the region?

Djalal: It's a wonderful product. We have started filing in Jordan, Morocco and Egypt and we will be filing in GCC countries very soon. We are very excited about it and have a high expectation.

PharmAsia News : How big is the market for Prolia in the Middle East?

Djalal: If you think of the individual countries, they are not big. I don't have the figures [but] I expect the total market could reach half a billion dollars. In individual countries, Morocco is definitely a larger market due to its large population, doubling that of Jordan. Amgen's largest market is Saudi Arabia, then South Africa; Algeria could be large as well, so is Egypt. These markets could reach a combined $500 million in sales.

PharmAsia News : Will Amgen collaborate with GlaxoSmithKline in this market? [Amgen signed a collaboration agreement on Prolia with GSK in emerging markets where Amgen doesn't have a commercial presence (Also see "Can Emerging Markets Fuel Growth And Restore Trust In Pharma?" - Scrip, 30 Nov, 2010.).]

Djalal: We are going to do it alone in the Middle East and even Africa. We will be managing the business. Except for a few countries, the whole region is kept within Amgen.

PharmAsia News : What's the time frame for Prolia to clear the regulatory process in the region?

Djalal: There are three steps: filing, approval and the most important part, pricing. I consider it the most important, even if you have obtained approvals, sometime the pricing is not cost effective.

NDA filing is already underway in some countries and approvals will depend on each market. The approvals in Morocco, South Africa take quite long; it can go to three years to get your approval. In GCC countries, the target approval time is usually one year plus or minus one quarter.

PharmAsia News : How do you handle the pricing issue? [Facing budgetary shortfalls and pressure to cut medical costs, governments across the region from Egypt to Turkey have slashed drug prices in waves in recent years (Also see "Egyptian Drug Price Reform: New Trade Barrier Or Demand Driver?" - Scrip, 28 Oct, 2010.).]

Djalal: We faced this issue one time, and we expected this issue coming. I appealed three times in Saudi Arabia and luckily the last appeal was accepted. We are still appealing and negotiating in Jordan. In Egypt, we convinced authorities to grant a more cost-effective price, based on a scientific argument. Sometime we can even show that considering cost-effectiveness and health economics, and other costs, the product is less costly than it has been perceived in a general picture.

We see this issue as a worldwide challenge. Companies develop strategies, and on the other side, regulators develop their counter strategies. It is not an easy task. You may spend six months to one year to get the price and at the same time, patients are not getting the product.

PharmAsia News : Which of your products face the most pricing challenges?

Djalal: As we don't have all five products registered in all the countries, and in the GCC, there are two products that are registered, Aranesp and Mimpara. With such a small product portfolio, we don't have much experience in pricing issues. As a biotech company, we make specialty products and oncology products which are usually considered expensive.

With only five products in the portfolio, we already feel this pricing issue. I could imagine how others [with larger portfolios] feel.

PharmAsia News : How do you choose which country to register?

Djalal: In the Middle East region, registration must be approved in the sourcing country before they can be approved. In the case of our products, they must be either U.S. FDA approved or approved and marketed in Europe, as a second and third wave. So we do wait and the regulatory filing comes a little later; it can be one to two years later. The exception is South Africa, which accepts simultaneous filing. However, the approval process is very long and can take two to three years.

- Brian Yang ([email protected])

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