Product Life-Cycle Management for Injectable Drugs: A Good Outlook for Proactive Market Players

Today, manufacturers of injectable drugs face many pressures, including the push to reduce drugs' applications and the desire for more-effective products and additional patient-friendly delivery systems. A viable product life-cycle management (PLM) strategy is a crucial tool that can help injectable-drug companies stay competitive in the marketplace.

Juergen Koch

PLM is a set of capabilities that enables a company to efficiently modify and manage its products and services throughout their life cycles. The central challenge facing a pharmaceutical company is to differentiate its products from its competitors' products. Getting a drug on the market is not enough. Managing its success is just as crucial.

Many companies launch their drugs quickly and develop a PLM strategy in parallel. This is true especially for first-class products. If you launch a first-class product as quickly as possible in a standard delivery form without devising a PLM strategy for the future, it will face great competition when other products enter the market in patient-friendly forms.

Injectable drugs for rheumatoid arthritis, multiple sclerosis, anemia, infertility, cancer, and thrombosis have benefited from successful PLM strategies. In many cases, success depends on one of three current PLM trends: reformulation, second-generation launches, and new-indication approvals.

Reformulations

In terms of parenterals, reformulation refers to the process of changing a lyophilized drug to a liquid or sustained-release formulation. PEGylation is one such process and is a PLM strategy trend for working with injectable drugs.

One benefit to reformulating a successful drug is that it helps protect against generic competition. Reformulations also are used to improve efficacy or patient-friendliness by, for exmple, reducing the frequency of injection.

Drug companies should remember that proper launch timing and competitive pricing contribute to successful reformulations. Companies can better plan for these considerations by developing a PLM strategy such as reformulation.

Second-generation launches

New delivery forms for existing products can increase market share. For example, a change from a vial or diluent to a prefilled syringe, cartridge, pen, or dual-chamber system (for lyophilized drugs) might make a product more patient-friendly and could increase sales.

Dual-chamber syringes, for example, are ideal for biologically sensitive formulations. They allow drugs to be lyophilized and packaged with their diluents. This technique permits healthcare professionals to reconstitute and administer drugs and reduce overfill.

A second-generation launch allows manufacturers to increase the market share established by earlier products because patients will likely switch to an improved version of a familiar drug. Products with great market potential—especially drugs for which indications continue to change and developers aim to create new and improved products—can succeed with this approach.

Packaging and new indications

Adding new indications for established products can be a viable and profitable strategy for companies that manufacture injectable drugs. New indications also can provide benefits to patients. For example, Interferon alpha was first launched to fight cancer, and later to treat hepatitis C.

Certain indications such as rheumatoid arthritis require innovative and often highly customized packaging and application systems. For example, prefilled syringes and autoinjectors are increasingly common because they meet the needs of this specific patient group and the growing home-care market.

Partnering

Whether the goal is reformulation, a second-generation launch, approval of new indications, or another PLM tactic, a partnership with an established leader in the drug-delivery field has proven to be a successful strategy for many firms specializing in injectable-drug manufacturing. Interferons for hepatitis and multiple sclerosis patients were originally lauched in vials, and later in the patient-friendly pen form. And, a successful partner is one who can join drug makers during every step along the way.

Juergen Koch is a managing director at Vetter Pharma-Fertigung GmbH & Co. KG, Schuetzenstr. 87, 88212 Ravensburg, Germany, tel. +49 751 3700 0, fax +49 751 3700 4000.